Intragastric device for treating obesity

ABSTRACT

An intragastric device including (1) a first wire mesh structure having a pre-deployment shape, a post-deployment shape greater than the pre-deployment state, and one or more openings on an upper portion of the first wire mesh structure that are configured to permit food to enter the device, (2) a second wire mesh structure having a pre-deployment shape a post-deployment shape greater than the pre-deployment state, and one or more openings on a lower portion of the second wire mesh structure that are configured to permit food to exit the device. A sleeve may be coupled to the lower portion of the wire mesh structure. An anti-migration collar may interconnect the wire mesh structure and the sleeve. In use, food enters the upper portion of the first wire mesh structure, passes through both wire mesh structures, and then exits the lower portion of the second wire mesh structure.

FIELD

The present specification relates generally to medical devices useful inthe treatment of obesity. More particularly, the present specificationrelates to intragastric and gastrointestinal devices of dynamic weightthat reduce gastric volume, slow gastric emptying, and/or bypassportions of the small intestine, thereby leading to patient weight loss.

BACKGROUND

Obesity is a common condition and growing public health problem indeveloped nations including the United States. As of 2009, more than twothirds of American adults, approximately 127 million people, were eitheroverweight or obese. Over one third of American adults are obese. Datasuggest that 300,000 Americans die prematurely from obesity-relatedcomplications each year. Many children in the United States are alsoeither overweight or obese. Hence, the overall number of overweightAmericans is expected to rise in the future. It has been estimated thatobesity costs the United States over $100 billion annually in direct andindirect health care expenses and in lost productivity. This trend isalso apparent in many other developed nations.

For adults, the body mass index (BMI) is used to determine if one isoverweight or obese. A person's BMI is calculated by multiplying bodyweight in pounds by 703 and then dividing the total by height in inchessquared. A person's BMI is expressed as kilograms per meter squared. Anadult is considered overweight if his or her BMI is between 25 and 30kg/m2. Obesity is defined as possessing a BMI between 30 and 40 kg/m2. ABMI greater than 30 kg/m2 is associated with significant co-morbidities.Morbid obesity is defined as possessing either a body weight more than100 pounds greater than ideal or a BMI greater than 40 kg/m2.Approximately 5% of the U.S. population meets at least one of thecriteria for morbid obesity. Morbid obesity is associated with manydiseases and disorders including, for example: diabetes; hypertension;heart attack; stroke; dyslipidemia; sleep apnea; pickwickian syndrome;asthma; lower back and disc disease; weight-bearing osteoarthritis ofthe hips, knees, ankles and feet; thrombophlebitis and pulmonary emboli;intertriginous dermatitis; urinary stress incontinence; gastroesophagealreflux disease (GERD); gallstones; and, sclerosis and carcinoma of theliver. In women, infertility, cancer of the uterus, and cancer of thebreast are additionally associated with morbid obesity. Taken together,the diseases associated with morbid obesity markedly reduce the odds ofattaining an average lifespan. The sequelae raise annual mortality ratesin affected people by a factor of 10 or more.

Current treatments for obesity include diet, exercise, behavioraltreatments, medications, surgery (open and laparoscopic), and endoscopicdevices. New drug treatments for obesity are currently being evaluatedin clinical trials. However, a high efficacy pharmaceutical treatmenthas not yet been developed. Further, short-term and long-term sideeffects of current pharmaceutical treatments often concern consumers,pharmaceutical providers, and/or their insurers. Generally, diet or drugtherapy programs have been consistently disappointing, failing to bringabout significant, sustained weight loss in the majority of morbidlyobese people.

Currently, most operations used to treat morbid obesity include gastricrestrictive procedures, involving the creation of a small (e.g., 15-35ml) upper gastric pouch that drains through a small outlet (e.g.,0.75-1.2 cm), setting in motion the body's satiety mechanism. About 15%of operations used to treat morbid obesity performed in the UnitedStates involve combining a gastric restrictive procedure with amalabsorptive procedure. Typical malabsorptive procedures divide smallintestinal flow into a biliary-pancreatic conduit and a food conduit.Potential long-term side effects associated with abdominal surgicalprocedures include herniation and small bowel obstruction. In addition,long-term problems specific to bariatric procedures also include gastricoutlet obstruction, marginal ulceration, protein malnutrition, andvitamin deficiency.

Other surgical strategies for treating obesity include endoscopicprocedures, many of which are still in development. Endoscopicprocedures and devices to produce gastric pouch and gastrojejunalanastomosis are used to replicate laparoscopic procedures.Endoscopically placed gastric balloons restrict gastric volume andresult in satiety with smaller meals. For example, U.S. patentapplication Ser. No. 10/221,562, now issued as U.S. Pat. No. 7,172,613and assigned to Districlass Medical SA, describes an “intragastricdevice inserted by endoscopic path into a patient's stomach. The deviceincludes a balloon or envelope having a specific nominal volume. Theballoon is sealingly connected to connecting elements consisting of adisc forming a support base for the balloon against an inner wall of thestomach. The device also includes a flexible tube or catheter forconnecting the balloon to a filling device and catching element integralwith the tube or catheter. The connection elements enable a doctor toset and/or remove the balloon and to fix, either inside the patient'sbody, or subcutaneously the filling device and to be able to bring theballoon or envelope to its predetermined nominal volume.”

The silicone intragastric balloon (IGB) has been developed as atemporary aid to achieve weight loss specifically for people who weigh40% or more of their ideal weight and who have had unsatisfactoryresults in their treatment of obesity, despite being cared for by amultidisciplinary team. This treatment is also indicated for morbidlyobese patients who have a high morbidity and mortality risk for surgery.The placement and removal of the IGB is an endoscopic procedure and theballoon is designed to float freely inside the stomach. The IGBtechnique reduces the volume of the stomach and leads to a prematurefeeling of satiety. However, use of IGBs did not show convincingevidence of a greater weight loss. The relative risks for minorcomplications, for example, gastric ulcers and erosions, weresignificantly raised. All inflatable IGB devices suffer from the problemof deterioration of the balloon over time. This deterioration can resultin deflation with loss of efficacy and complications such as small bowelobstruction secondary to balloon migration. Due to loss of efficacy overtime, IGB devices are recommended only for short (<6 month) durations.In addition, rapid inflation of the balloon poses the risk of esophagealor gastric perforations, both of which are surgical emergencies. Deathshave been reported in patients using IGB treatment.

Endoscopic procedures are also used to deploy mesh structures into thestomach in an effort to occupy stomach volume and create the artificialsensation of being full. For example, U.S. patent application Ser. No.11/657,231, assigned to Wilson-Cook Medical, Inc., describes an“intragastric device generally compris[ing] a strip digestive-resistantmesh material that is operable between a first configuration and asecond configuration. The first configuration is sufficiently small topermit introduction of the digestive-resistant mesh material into agastric lumen of the mammal. The second configuration is sufficientlylarge to prevent the digestive-resistant mesh material from passingthrough the mammal's pylorus, thereby permitting the mesh member to actas an artificial bezoar.”

Although endoscopically placed balloon structures can be effective, theyare not without their associated risks and complications. Meshstructures are effective in occupying available gastric volume but theydo not address gastric emptying. Migration and small bowel obstructionfrom such devices continue to remain a significant problem. Therefore, aneed exists for an intragastric device to treat obesity that combinesthe benefits obtained through reducing stomach volume, slowing gastricemptying, and providing a bypass for food past the pylorus and a portionof the small intestine, while remaining relatively safe. The deviceshould also include a component for preventing migration of the entiredevice out of the stomach. This device should limit side effects and beable to be deployed and removed in a non-invasive manner with relativeease. In addition, this device should have the option of furthertreating obesity by including the benefits obtained by malabsorptivediversion procedures. The addition of this optional benefit would makethe device effective in treating not only obesity, but type II diabetesas well.

Typical metal structures cannot survive the hostile environment,particularly with respect to the high acidity, of the stomach.Intragastric devices comprising acid-sensitive components, such as metalwires, are typically covered or coated in an acid-resistant material(i.e. silicone) to prevent degradation of these components by acidicgastric contents. Conventional manufacturing processes for creatingthese coated intragastric devices first coat the metal wires of thedevice and then form the wires into the desired end shape of the device.As the shapes and structures of intragastric devices become morecomplicated, these conventional processes are unable to properly createthe desired end product. A shape memory metal, such as Nitinol, isheat-set at temperatures in excess of 400° C. Coating the metal with anacid-resistant material and then heat-setting into the final shape wouldresult in destruction of the coating during exposure to the hightemperatures. Therefore, a method of manufacture is needed wherein thewires of the intragastric device are first formed into the desired endshape and are then coated with a corrosion-resistant material. Such amethod will take care to prevent the coating and covering or clogging ofthe spaces or openings between the wires of the wire mesh. Such a methodwill also produce a finished device that is still flexible enough to beconverted from a compressed, first pre-deployment shape to an expanded,post-deployment shape.

Specific surgical options for the treatment of obesity also includelaparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y-gastricbypass (RGB) surgery. Gastrectomy refers to a partial or full surgicalremoval of the stomach. LSG is a restrictive treatment, surgicalweight-loss procedure in which the stomach is reduced to approximately25% of its original size by surgical removal of a large portionfollowing the major curve. The open edges are then attached together(often with surgical staples) to form a sleeve or tube with a bananashape. The procedure permanently reduces the size of the stomach. Theprocedure is performed laparoscopically and is not reversible. Followingthe operation, the stomach empties its contents rapidly into the smallintestine, but with little or no vomiting (characteristic of otherrestrictive procedures).

LSG involves a longitudinal resection of the stomach on the greatercurvature from the antrum starting opposite the nerve of Latarjet up tothe angle of His. The first step of the procedure is the division of thevascular supply of the greater curvature of the stomach which isachieved with the section of the gastro-colic and gastro-splenicligaments close to the stomach. The greater curvature is completelyfreed up to the left crus of the diaphragm to resect the gastric fundusthat harbors the ghrelin secreting cells of the stomach. The second stepof the procedure is the longitudinal gastrectomy that “sleeves” thestomach to reduce its shape to a narrow tube. The pylorus and part ofthe antrum are preserved, resulting in a lesser curvature-based“restrictive” gastric sleeve.

Sleeve gastrectomy (also called gastric sleeve) is usually performed onextremely obese patients, with a body mass index of 40 or more, wherethe risk of performing a gastric bypass or duodenal switch procedure maybe too large. A two-stage procedure is performed: the first is a sleevegastrectomy; the second is a conversion into a gastric bypass orduodenal switch. Patients usually lose a large quantity of their excessweight after the first sleeve gastrectomy procedure but, if weight lossceases, the second step is performed.

For patients that are obese but not extremely obese, sleeve gastrectomyalone is a suitable operation with minimal risks. The sleeve gastrectomyis currently an acceptable weight loss surgery option for obese patientsas a single procedure. Most surgeons prefer to use a bougie (taperingcylindrical instrument) having an outer diameter between 32-60 French(the optimal bougie size is 32 Fr-36 Fr) with the procedure. The idealapproximate remaining capacity of the stomach after the procedure is 15ml.

One of the mechanisms involved in weight loss observed after the LSG isthe dramatic reduction of the capacity of the stomach. The concept ofrestriction has been widely used in bariatric surgery in vertical bandedgastroplasty (VBG) and laparoscopic adjustable gastric banding (LAGB).The distension of the small gastric pouch in the LAGB procedure or VBGis intended to account for the feeling of early fullness, enhancedsatiety and decreased hunger experienced by a patient after theingestion of small quantities of food.

The hormonal modifications induced by LSG differ from those found aftera purely restrictive procedure such as LAGB. Ghrelin, a peptide hormonemainly produced in the fundus of the stomach, is believed to be involvedin the mechanisms regulating hunger. There is a significant reduction inghrelin associated with resection of the gastric fundus.

What makes LSG a preferable option lies in the fact that the operationis a straightforward procedure that can generally be completedlaparoscopically, even in the case of an extremely obese patient. Itdoes not involve any digestive anastomosis and no mesenteric defects arecreated, eliminating the risk of internal hernia. In addition, noforeign material is used as in the case of gastric banding, the wholedigestive tract remains accessible to endoscopy, and it is notassociated with Dumping syndrome. Also, the risk of peptic ulcer is lowand the absorption of nutrients, vitamins, minerals and drugs is notaltered.

Early reports of LSG have shown it to be safe and effective with markedweight loss and significant reduction of major obesity-relatedcomorbidities. The question whether LSG may work as a sole bariatricprocedure in the long term cannot yet be answered. For this reason, LSGis proposed as the first step of a staged approach in patients for whoma biliopancreatic diversion with duodenal switch (BPD-DS) or RGB seemstoo hazardous because of a very high BMI (super obesity=BMI>50 orsuper-super obesity=BMI>60) and/or associated diseases whether relatedor not to obesity.

Laparoscopic roux-en-y-gastric bypass (RGB) involves the creation of asmall (20-30 ml) gastric pouch and a Roux limb (typically 75-105 cm)that reroutes a portion of the alimentary tract to bypass the distalstomach and proximal small bowel. Following RGB, a pleiotropic endocrineresponse may contribute to improved glycemic control, appetitereduction, and long-term changes in body weight. RGB also has aprofoundly positive impact on obesity-related comorbidities and qualityof life. Other advantages include established long-term effectivenessfor sustained weight loss, reduction of comorbidities, minimal risk forlong-term nutritional sequelae, and effective relief of gastroesophagealreflux disease (GERD). RGB is not without risks. Common causes of deathinclude pulmonary embolism and anastomotic leaks. Nonfatal perioperativecomplications include anastomotic leaks, venous thromboembolism, woundinfections, small bowel obstruction, and bleeding. Postoperativegastrointestinal complications include nausea and vomiting,micronutrient deficiencies, and possible weight regain.

Failures after these bariatric procedures are common and patients startregaining weight or the progressive weight loss stops at asub-therapeutic level. Therefore, there is a need for salvage therapyafter one or more failed bariatric procedures. What is needed is adevice to be used following bariatric surgery that will combine thebenefits of gastric volume reduction, bilio-pancreatic diversion and/orintestinal bypass to enhance the weight loss effects of the device. Whatis also needed is a device that will further reduce the volume of asurgically restricted stomach to reduce the amount of calories that canbe consumed. The device will also bypass the proximal small intestine orthe roux limb of the intestine in order to produce intestinal malabsorption, bilio-pancreatic diversion or both. The device can furtheract to delay gastric emptying, release the gastric hormones associatedwith satiety, and stimulate the gastric nerves associated with sensationof satiety. The device could be combined with other therapeutic agentssuch as electrical stimulation, magnetic stimulation, or pharmaceuticalagents.

The device can be used as a primary therapeutic procedure for weightloss or as a bridge to surgery for a definitive weight loss procedure.The device may also be used in the treatment of other conditionsincluding, but not limited to, metabolic syndrome, diabetes mellitus,dyslipidemias and cardiovascular disease.

SUMMARY

The present specification discloses an intragastric device configuredfor deployment in a stomach of a person, said device comprising: acatheter comprising a housing and a lumen extending through saidhousing, wherein the lumen has an internal diameter and wherein theinternal diameter is equal to or less than 2 cm; a first wire meshstructure having a pre-deployment shape that is compressed within saidlumen of the catheter and a post-deployment shape that is expandedwithin the stomach of the person, wherein said pre-deployment shape hasa first volume that is equal or less than 110 ml and a first length thatis equal to or less than 75 cm and wherein said post-deployment shapehas a porous, enclosed second volume, defined by a first plurality ofcurved surfaces, that is equal to or greater than 125 ml, said firstwire mesh structure further comprising an upper portion and a lowerportion wherein the upper portion has a first surface area of openingsconfigured to permit material to enter from outside the second volume toinside the second volume and wherein the lower portion has a secondsurface area of openings; a second wire mesh structure, separate fromthe first wire mesh structure, having a pre-deployment shape that iscompressed within said lumen of the catheter and a post-deployment shapethat is expanded within the stomach of the person, wherein saidpre-deployment shape has a third volume that is equal or less than 100ml and a second length that is equal to or less than 70 cm and whereinsaid post-deployment shape has a porous, enclosed fourth volume, definedby a second plurality of curved surfaces, that is equal to or greaterthan 110 ml, said second wire mesh structure further comprising an upperportion and a lower portion wherein the upper portion has a thirdsurface area of openings configured to permit material to enter fromoutside the fourth volume to inside the fourth volume and wherein thelower portion has a fourth surface area of openings; a connection toflexibly couple said first and second wire mesh structures, wherein saidconnection is formed between a portion of the first wire mesh structuredefining said second surface area of openings and a portion of thesecond wire mesh structure defining said third surface area of openings.

The first wire mesh structure and the second wire mesh structure may bepositioned serially within the lumen of the catheter.

Optionally, at least one of the first plurality of curved surfaces isdefined by an arc and wherein said arc is determined by a radius in arange of 0.2 cm to 20 cm and a central angle in a range of 5 to 175degrees.

Optionally, at least one of the second plurality of curved surfaces isdefined by an arc and wherein said arc is determined by a radius in arange of 0.1 cm to 15 cm and a central angle in a range of 1 to 179degrees.

Optionally, said connection is formed between a portion of a pluralityof free ends of the first wire mesh structure defining said secondsurface area of openings and a portion of a plurality of free ends ofthe second wire mesh structure defining said third surface area ofopenings.

The first wire mesh structure and second wire mesh structure may have atleast one of a spherical and elliptical shape.

Optionally, said connection comprises a plurality of sutures.Optionally, the plurality of sutures include a first flexible sutureattached, at one end, to a first point on said second surface area ofopenings and, at a second end, to a second point on said third surfacearea of openings.

A length of a connection, from the first point on the second surfacearea of openings to the second point on said third surface area ofopenings, may be in a range of 0.01 mm to 200 mm.

Optionally, said plurality of sutures include a second flexible sutureattached, at one end, to a third point on said second surface area ofopenings and, at a second end, to a fourth point on said third surfacearea of openings, wherein said first point is different from the thirdpoint and wherein said second point is different from the fourth point.A length of a connection, from the third point on the second surfacearea of openings to the fourth point on said third surface area ofopenings, may be in a range of 0.01 mm and 300 mm. The first flexiblesuture and the second flexible suture may be separated by 180 degrees.Optionally, the plurality of sutures include a third flexible sutureattached, at one end, to a fifth point on said second surface area ofopenings and, at a second end, to a sixth point on said third surfacearea of openings, wherein said fifth point is different from the firstpoint and the third point and wherein said sixth point is different fromthe second point and the fourth point. A length of a connection, fromthe fifth point on the second surface area of openings to the sixthpoint on said third surface area of openings, may be in a range of 0.01mm and 300 mm. Optionally, the plurality of sutures include a fourthflexible suture attached, at one end, to a seventh point on said secondsurface area of openings and, at a second end, to a eighth point on saidthird surface area of openings, wherein said seventh point is differentfrom the first point, the third point, and the fifth point and whereinsaid eighth point is different from the second point, the fourth pointand the sixth point. A length of a connection, from the seventh point onthe second surface area of openings to the eighth point on said thirdsurface area of openings, is in a range of 0.01 mm and 300 mm.

Optionally, the first and second wire mesh structures have a degree ofmovement in all directions relative to each other, said degree ofmovement being defined by an angular displacement between a firstlongitudinal axis passing through a center of said first wire meshstructure, a center of the first surface area of openings, and a centerof the second surface area of openings and a second longitudinal axispassing through a center of said second wire mesh structure, a center ofthe third surface area of openings, and a center of the fourth surfacearea of openings. The angular displacement may be equal to, or lessthan, 90 degrees.

Optionally, the connection of said first wire mesh structure to thesecond wire mesh structure has a length such that the first wire meshstructure can be compressed up to 99% of its equatorial diameter withoutleading to a compression of said second wire mesh structure.

Optionally, the connection of said first wire mesh structure to thesecond wire mesh structure has a length such that, upon more than 90%compression of the first wire mesh structure, the second wire meshstructure has an angular displacement relative to the first wire meshstructure of 10% or less, wherein said angular displacement is definedby a relative angle between a first longitudinal axis passing through acenter of said first wire mesh structure, a center of the first surfacearea of openings, and a center of the second surface area of openingsand a second longitudinal axis passing through a center of said secondwire mesh structure, a center of the third surface area of openings, anda center of the fourth surface area of openings.

Optionally, the first wire mesh structure and the second wire meshstructure are connected by said connection within the lumen of thecatheter.

Optionally, the first wire mesh structure and the second wire meshstructure are not connected by said connection within the lumen of thecatheter.

Optionally, the connection is formed by interweaving a portion of aplurality of free ends of said second surface area of openings and aportion of a plurality of free ends of said third surface area ofopenings.

The second and fourth volumes together may occupy 25% to 95% of thestomach.

Optionally, the intragastric device further comprises a sleeve having aproximal end, a distal end, and a lumen, wherein said proximal end iscoupled to said lower portion of said second wire mesh structure andsaid distal end is positioned in a duodenum of a patient, said sleevefurther comprising a first opening in fluid communication with saidfourth surface area of openings and a second opening at said distal end,wherein said sleeve is configured to transmit food from saidintragastric device to said duodenum.

Optionally, the first wire mesh structure has at least one of aspherical shape and an elliptical shape and the first wire meshstructure has a volume that is greater than 5 ml and less than 5000 ml.

Optionally, the second wire mesh structure has at least one of aspherical shape and an elliptical shape and the second wire meshstructure has a volume that is greater than 20 ml and less than 4000 ml.

The present specification also discloses an intragastric deviceconfigured for deployment in a stomach of a person, said devicecomprising: a first wire mesh structure having a pre-deployment shapethat is compressed within a lumen of a catheter and a post-deploymentshape that is expanded within the stomach of the person, wherein saidpre-deployment shape has a first volume that is equal or less than 110ml and a first length that is equal to or less than 75 cm and whereinsaid post-deployment shape has a porous, enclosed second volume, definedby a first plurality of curved surfaces, that is equal to or greaterthan 125 ml, said first wire mesh structure further comprising an upperportion and a lower portion wherein the upper portion has a firstsurface area of openings configured to permit material to enter fromoutside the second volume to inside the second volume and wherein thelower portion has a second surface area of openings; a second wire meshstructure having a pre-deployment shape that is compressed within saidlumen of the catheter and a post-deployment shape that is expandedwithin the stomach of the person, wherein said pre-deployment shape hasa third volume that is equal or less than 100 ml and a second lengththat is equal to or less than 70 cm and wherein said post-deploymentshape has a porous, enclosed fourth volume, defined by a secondplurality of curved surfaces, that is equal to or greater than 110 ml,said first wire mesh structure further comprising an upper portion and alower portion wherein the upper portion has a third surface area ofopenings configured to permit material to enter from outside the fourthvolume to inside the fourth volume and wherein the lower portion has afourth surface area of openings; a plurality of flexible members toflexibly couple said first and second wire mesh structures, wherein saidplurality of flexible members include a first flexible member attached,at one end, to a first point on said second surface area of openingsand, at a second end, to a second point on said third surface area ofopenings and wherein said plurality of flexible members include a secondflexible member attached, at one end, to a third point on said secondsurface area of openings and, at a second end, to a fourth point on saidthird surface area of openings, wherein said first point is differentfrom the third point and wherein said second point is different from thefourth point.

Optionally, a length of said first flexible member, from the first pointon the second surface area of openings to the second point on said thirdsurface area of openings, is in a range of 0.01 mm and 300 mm.

Optionally, a length of said second flexible member, from the thirdpoint on the second surface area of openings to the fourth point on saidthird surface area of openings, is in a range of 0.01 mm and 100 mm.

The first flexible member and the second flexible member may beseparated by 180 degrees.

Optionally, the plurality of flexible members include a third flexiblemember attached, at one end, to a fifth point on said second surfacearea of openings and, at a second end, to a sixth point on said thirdsurface area of openings, wherein said fifth point is different from thefirst point and the third point and wherein said sixth point isdifferent from the second point and the fourth point. A length of saidthird flexible member, from the fifth point on the second surface areaof openings to the sixth point on said third surface area of openings,may be in a range of 0.01 mm and 300 mm. Optionally, the plurality offlexible members include a fourth flexible member attached, at one end,to a seventh point on said second surface area of openings and, at asecond end, to a eighth point on said third surface area of openings,wherein said seventh point is different from the first point, the thirdpoint, and the fifth point and wherein said eighth point is differentfrom the second point, the fourth point and the sixth point. A length ofsaid fourth flexible member, from seventh point on the second surfacearea of openings to the eighth point on said third surface area ofopenings, may be in a range of 0.01 mm and 100 mm.

Optionally, the first and second wire mesh structures have a degree ofmovement in all directions relative to each other, said degree ofmovement being defined by an angular displacement between a firstlongitudinal axis passing through a center of said first wire meshstructure, a center of the first surface area of openings, and a centerof the second surface area of openings and a second longitudinal axispassing through a center of said second wire mesh structure, a center ofthe third surface area of openings, and a center of the fourth surfacearea of openings. The angular displacement may be equal to, or lessthan, 90 degrees.

Optionally, each of the plurality of flexible members has a length suchthat the first wire mesh structure can be compressed up to 95% of itsequatorial diameter without leading to a compression of said second wiremesh structure.

Optionally, each of the plurality of flexible members has a length suchthat, upon more than 90% compression of the first wire mesh structure,the second wire mesh structure has an angular displacement relative tothe first wire mesh structure of 10% or less, wherein said angulardisplacement is defined by a relative angle between a first longitudinalaxis passing through a center of said first wire mesh structure, acenter of the first surface area of openings, and a center of the secondsurface area of openings and a second longitudinal axis passing througha center of said second wire mesh structure, a center of the thirdsurface area of openings, and a center of the fourth surface area ofopenings.

The present specification also discloses an intragastric deviceconfigured for deployment in a stomach of a person, said devicecomprising: a catheter comprising a housing and a lumen extendingthrough said housing, wherein the lumen has an internal diameter andwherein the internal diameter is equal to or less than 2 cm; a firstwire mesh structure having a pre-deployment shape that is compressedwithin said lumen of the catheter and a post-deployment shape that isexpanded within the stomach of the person, wherein said pre-deploymentshape has a first volume that is equal or less than 110 ml and a firstlength that is equal to or less than 75 cm and wherein saidpost-deployment shape has a porous, enclosed second volume, defined by afirst plurality of curved surfaces, that is equal to or greater than 125ml, said first wire mesh structure further comprising a first upperportion and a first lower portion wherein the first upper portion has afirst opening configured to permit material to enter from outside thesecond volume to inside the second volume, and wherein the lower portionhas a portion of said first plurality of curved surfaces that taper andconverge into a second opening defined by a diameter; and a collarattached to the lower portion, wherein said collar is defined by asurface of revolution generated by revolving a semi-circle inthree-dimensional space about an axis extending through a center of thesecond opening and wherein said collar is defined by a diameter that isequal to or greater than 25 mm.

The present specification also discloses a delivery device fordelivering a gastrointestinal device into a gastrointestinal tract of apatient, said gastrointestinal device comprising a porous structureconfigurable between a compressed pre-deployment configuration and anexpanded post-deployment configuration, an anti-migration collarproximate a distal end of said porous structure, and an elongate sleevecoupled to the distal end of said porous structure, said delivery devicecomprising: a flexible outer catheter having a proximal end, a distalend, and a lumen; a flexible inner catheter having a proximal end, adistal end, and a lumen configured to slidably receive a guide wire,wherein said inner catheter is positioned coaxially and is configured tobe slidably movable within the lumen of said outer catheter; whereinsaid outer catheter is configured to be retracted in a proximaldirection over said inner catheter while maintaining said inner catheterin place to expose said gastrointestinal device from said distal end ofsaid delivery device.

Optionally, said sleeve has length such that, once said gastrointestinaldevice is delivered, a proximal end of said sleeve is positionedproximal to a patient's pylorus and a distal end of said sleeve ispositioned in a portion of a patient's duodenum.

Optionally, said outer catheter has a length of approximately 1.5 metersand said delivery device has an overall length of approximately 3meters.

Optionally, the anti-migration collar of the gastrointestinal device isproximally sloping wherein a distal portion of the porous structure isfolded such that the distally directed end of the porous structure ismade to point toward the proximal end of the porous structure.Optionally, the anti-migration collar is any curved/atraumatic structurepositioned circumferentially around the distal end of the porousstructure.

Optionally, the outer catheter includes a radiopaque marker at itsdistal end for radiographic visualization during delivery.

Optionally, the delivery device further comprises: a first handleattached to the proximal end of said inner catheter and having aproximal end, a distal end, and a lumen configured to slidably receivesaid guide wire; a second handle attached to the proximal end of saidouter catheter and having a proximal end, a distal end, and a lumenconfigured to slidably receive said inner catheter, wherein, prior todelivery of said intragastric device, a proximal portion of said innercatheter positioned between said first and second handles is exposed andnot covered by said outer catheter; an elongate flexible pilot componenthaving a proximal end, a distal end and a length having a variablestiffness, said pilot component comprising a distal spherical componentand a proximal spherical component and extending from said distal end ofsaid inner catheter; a first stopping mechanism removably attached tosaid exposed portion of said inner catheter; and a second stoppingmechanism removably attached to said exposed portion of said innercatheter and positioned proximal to said first stopping mechanism;wherein said first and second stopping mechanisms are configured to besequentially removed from said inner catheter as said outer catheter isretracted.

The delivery device may further comprise a hydrophilic coating over atleast one of said pilot component and said distal end of said outercatheter, wherein, when activated, said hydrophilic coating is adaptedto ease insertion and navigation of said delivery device.

The delivery device may further comprise a port on at least one of saidfirst handle for injecting a fluid into said lumen of said innercatheter and said second handle for injecting a fluid into said lumen ofsaid outer catheter.

Optionally, said proximal spherical component is configured to beatraumatic and includes a radiopaque marker for radiographicvisualization during delivery and said distal spherical component isconfigured in an atraumatic ball-tip shape.

Optionally, said variable stiffness of said pilot component is less thana stiffness of said distal end of said outer catheter at its proximalend and similar to a stiffness of a 0.035 inch guide wire at its distalend.

Optionally, said first and second stopping mechanisms comprise plasticrings secured to said inner catheter using wing nuts.

The present specification also discloses a method of delivering agastrointestinal device, using a delivery device, into agastrointestinal tract of a patient, said gastrointestinal devicecomprising a porous structure configurable between a compressedpre-deployment configuration and an expanded post-deploymentconfiguration, an anti-migration collar proximate a distal end of saidporous structure, and an elongate sleeve coupled to a distal end of saidporous structure, said delivery device comprising a flexible outercatheter having a proximal end, a distal end, and a lumen; a flexibleinner catheter having a proximal end, a distal end, and a lumenconfigured to slidably receive a guide wire, wherein said flexible innercatheter is positioned coaxially, and is adapted to be slidably movable,within the lumen of said outer catheter; a first handle attached to theproximal end of said inner catheter and having a proximal end, a distalend, and a lumen configured to slidably receive said guide wire; asecond handle attached to the proximal end of said outer catheter andhaving a proximal end, a distal end, and a lumen configured to slidablyreceive said inner catheter, a first stopping mechanism removablyattached to an exposed portion of said inner catheter; and a secondstopping mechanism removably attached to said exposed portion of saidinner catheter and positioned proximal to said first stopping mechanism,said method comprising the steps of: sliding said delivery device over aguide wire and into said gastrointestinal tract of said patient; usingfluoroscopy to determine a location of said distal end of said flexibleouter catheter to ensure a correct positioning of said delivery device;holding said first handle to keep said inner catheter in place andretracting said outer catheter to said first stopping mechanism;retracting the entire delivery device until said distal end of saidouter catheter is positioned just proximal to a pylorus of the patient;removing said first stopping mechanism from said inner catheter; holdingsaid first handle to keep said inner catheter in place and retractingsaid outer catheter to said second stopping mechanism; removing saidsecond stopping mechanism; holding said first handle to keep said innercatheter in place and retracting said outer catheter to said firsthandle; and removing said delivery device from said patient.

Optionally, when said outer catheter is retracted to said first stoppingmechanism, a portion of said sleeve is delivered to, and positionedwithin, an intestinal portion of said patient's gastrointestinal tract.

Optionally, when said outer catheter is retracted to said secondstopping mechanism, a portion of said sleeve and a portion of saidporous structure are delivered to, and positioned within, a stomachportion of said patient's gastrointestinal tract.

Optionally, when said outer catheter is retracted to said first handle,all of said porous structure is delivered to, and positioned within, astomach portion of said patient's gastrointestinal tract.

Optionally, the anti-migration collar of the gastrointestinal device isproximally sloping wherein a distal portion of the porous structure isfolded such that the distally directed end of the porous structure ismade to point toward the proximal end of the porous structure.Optionally, the anti-migration collar is any curved/atraumatic structurepositioned circumferentially around the distal end of the porousstructure.

Prior to delivery of said gastrointestinal device, a proximal portion ofsaid inner catheter positioned between said first and second handles maybe exposed and not covered by said outer catheter.

Optionally, said delivery device further comprises an elongate flexiblepilot component having a distal spherical component and a proximalspherical component and extending from said distal end of said innercatheter.

At least one of said pilot component and said distal end of said outercatheter may include a hydrophilic coating and said method may furthercomprise activating said hydrophilic coating before sliding saiddelivery device over said guide wire.

The present specification also discloses a delivery system fordelivering a gastrointestinal device into a gastrointestinal tract of apatient, said system comprising: a gastrointestinal device comprising: aporous structure configurable between a compressed pre-deploymentconfiguration and an expanded post-deployment configuration; ananti-migration collar proximate a distal end of said porous structure;and an elongate sleeve coupled to a distal end of said porous structure;a delivery device comprising: a flexible outer catheter having aproximal end, a distal end, and a lumen; a flexible inner catheterhaving a proximal end, a distal end, and a lumen configured to slidablyreceive a guide wire, wherein said inner catheter is positionedcoaxially and is adapted to be slidably movable within the lumen of saidouter catheter; a first handle attached to the proximal end of saidinner catheter and having a proximal end, a distal end, and a lumenconfigured to slidably receive said guide wire; a second handle attachedto the proximal end of said outer catheter and having a proximal end, adistal end, and a lumen configured to slidably receive said innercatheter, wherein a proximal portion of said inner catheter positionedbetween said first and second handles is not covered in its entirety bysaid outer catheter; an elongate flexible component comprising a distalspherical component and a proximal spherical component and extendingfrom said distal end of said inner catheter; a first stopping mechanismremovably attached to said exposed portion of said inner catheter; asecond stopping mechanism removably attached to said exposed portion ofsaid inner catheter and positioned proximal to said first stoppingmechanism; wherein said distal end of said inner catheter is adapted tobe passed through openings of said porous structure, wherein said sleeveis wrapped coaxially about said inner catheter, wherein said outercatheter may be retracted in a proximal direction over said innercatheter while maintaining said inner catheter in place, and whereinsaid first and second stopping mechanisms are adapted to be sequentiallyremoved from said inner catheter as said outer catheter is retracted toexpose and deliver the gastrointestinal device from said distal end ofsaid delivery device.

The delivery system may further comprise a hydrophilic coating over atleast one of said elongate flexible component and said distal end ofsaid outer catheter, wherein, when said hydrophilic coating isactivated, the hydrophilic coating eases insertion and navigation ofsaid delivery device.

The delivery system of claim may further comprise a port on at least oneof said first handle for injecting a fluid into said lumen of said innercatheter and said second handle for injecting a fluid into said lumen ofsaid outer catheter.

Optionally, said delivery devise has a variable stiffness along itslength.

Optionally, the anti-migration collar of the gastrointestinal device isproximally sloping wherein a distal portion of the porous structure isfolded such that the distally directed end of the porous structure ismade to point toward the proximal end of the porous structure.Optionally, the anti-migration collar is any curved/atraumatic structurepositioned circumferentially around the distal end of the porousstructure.

The present specification also discloses a delivery device forendoscopically delivering an intragastric device into a gastrointestinaltract of a patient, said intragastric device comprising a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said porous structure, said delivery devicecomprising: an elongate body having a proximal end and a distal end;and, a restraining mechanism for constricting said device in saidpre-deployment configuration coaxially over said distal end of saidelongate body.

In one embodiment, the delivery device further comprises a lockingmechanism for locking said delivery device in a specific position.

In one embodiment, said distal end comprises a most distal portion and aproximal distal portion, wherein said most distal portion is moreflexible than said proximal distal portion.

In one embodiment, the delivery device further comprises a thread pullport on said proximal end, wherein said restraining mechanism comprisesa thread wrapped about said device in said pre-deployment configuration.

In one embodiment, said restraining mechanism comprises a zipped sheathcoaxially covering said device in said pre-deployment configuration. Inanother embodiment, said restraining mechanism comprises a pull awaysheath coaxially covering said device in said pre-deploymentconfiguration. In another embodiment, said restraining mechanismcomprises a tear away sheath coaxially covering said device in saidpre-deployment configuration.

The delivery device may comprise an elongate body having a proximal end,a distal end, and a pull away sheath for coaxially sliding over saidintragastric device for constricting said intragastric device in saidpre-deployment configuration coaxially over said distal end of said bodyof said delivery device, and a method of delivering said intragastricdevice may comprise the steps of: coaxially placing said constrictedintragastric device in said pre-deployment configuration over saiddistal end of said body of said delivery device; endoscopicallyinserting said delivery device into a patient and advancing said distalend of said body of said delivery device to a duodenum or jejunum ofsaid patient; once intragastric device is positioned, using a workingtool to pull said sheath coaxially away to remove said sheath from saidconstricted intragastric device, allowing said intragastric device toautomatically expand into said post-deployment configuration; and,sliding said distal end of said body of said delivery device coaxiallyaway from said expanded intragastric device and removing said deliverydevice from said patient.

Optionally, the method further comprises the step of applying a coolingelement to said compressed intragastric device to slow the expansion ofsaid porous structure during removal of said sheath, facilitating theremoval of said delivery device.

The present specification also discloses a retrieval device forendoscopically removing an intragastric device from a gastrointestinaltract of a patient, said intragastric device comprising a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and including at least onecircumferential constricting mechanism positioned about said porousstructure and a retrieval mechanism at its proximal end and, an elongatesleeve coupled to a distal end of said porous structure, said retrievaldevice comprising: an elongate body having a proximal end and a distalend and a lumen within; an elongate metal wire disposed within saidlumen and having a proximal end and a distal end; a grasping mechanismformed from said distal end of said wire for grasping a free end of saidat least one circumferential constricting mechanism and said retrievalmechanism of said porous structure; and, an actuator attached to saidproximal end of said wire.

Optionally, the retrieval device further comprises a handle at saidproximal end of said elongate body.

Optionally, said actuator rests in said handle.

In one embodiment, the retrieval device further comprises a grasperhaving two opposing jaws attached to said distal end of said elongatebody and operatively connected to said actuator at said proximal end ofsaid wire and at least one clamp positioned between said jaws of saidgrasper wherein said jaws are configured to compress said clamp aboutsaid free end of said at least one circumferential constrictingmechanism.

The present specification also discloses a method of delivering anintragastric device into the gastrointestinal tract of a patient using adelivery device, wherein said intragastric device comprises a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said porous structure, said method comprisingthe steps of: deploying said porous structure without said sleeve andallowing said porous structure to expand into said post-deploymentconfiguration in a first procedure; deploying said sleeve within saidexpanded porous structure in a second procedure; and coupling a proximalend of said sleeve to a distal end of said porous structure during saidsecond procedure.

Optionally, the method further comprises the step of applying a coolingelement to said compressed intragastric device during said firstprocedure to slow the expansion of said porous structure duringdeployment.

Optionally, said first procedure is performed using a first catheter.

Optionally, said second procedure is performed using a second catheter.

The present specification also discloses a method of retrieving a devicefrom a gastrointestinal tract of a patient using a retrieval device,wherein said device comprises a porous structure configurable between acompressed pre-deployment configuration and an expanded post-deploymentconfiguration and includes at least one circumferential constrictingmechanism positioned about said porous structure and a retrievalmechanism at its proximal end and, an elongate sleeve coupled to adistal end of said porous structure, and said retrieval device comprisesan elongate body having a proximal end and a distal end and a lumenwithin, an elongate metal wire disposed within said lumen and having aproximal end and a distal end, a grasping mechanism formed from saiddistal end of said wire for grasping a free end of said at least onecircumferential constricting mechanism and said retrieval mechanism ofsaid porous structure, and an actuator attached to said proximal end ofsaid wire, said method comprising the steps of: endoscopically insertingsaid retrieval device into said patient and advancing said distal end ofsaid body of said retrieval device to a proximal end of said device;manipulating said grasping mechanism of said retrieval device to engagea free end of said at least one circumferential constricting mechanismpositioned about said porous structure; pulling on said actuator of saidretrieval device to constrict and automatically lock said at least onecircumferential constricting mechanism, thereby compressing said porousstructure into said pre-deployment shape; manipulating said graspingmechanism of said retrieval device to disengage said free end of said atleast one circumferential constricting mechanism; manipulating saidgrasping mechanism to engage said retrieval mechanism at said proximalend of said porous structure; pulling said actuator to withdraw aproximal portion of said device into said lumen of said retrievaldevice; and, removing said retrieval device and said device from saidpatient.

The intragastric device may include three circumferential constrictingmechanisms positioned about said porous structure and said method mayfurther comprise the steps of: sequentially manipulating said graspingmechanism of said retrieval device to engage a free end of each of saidthree circumferential constricting mechanisms; and pulling on saidactuator of said retrieval device to constrict and automatically lockeach of said three circumferential constricting mechanisms, therebyfully compressing said porous structure into said pre-deployment shape.

In one embodiment, the method further comprises the step of applying acooling element to said compressed device to prevent the re-expansion ofsaid porous structure during removal of said retrieval device and saiddevice.

The retrieval device may further comprise a grasper having two opposingjaws attached to said distal end of said elongate body and operativelyconnected to said actuator at said proximal end of said wire, and atleast one clamp positioned between said jaws of said grasper, and saidmethod may further comprise the step of manipulating said grasper ofsaid retrieval device to apply said at least one clamp to said free endof said at least one circumferential constricting mechanism proximatesaid compressed porous structure.

The present specification also discloses a retrieval device forendoscopically removing an intragastric device from a gastrointestinaltract of a patient, said intragastric device comprising a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and including an elongatesleeve coupled to a distal end of said porous structure, said retrievaldevice comprising: a flexible catheter having a proximal end, a distalend, and a lumen within; an elongate wire positioned within said lumenof said catheter and having a proximal end and a distal end wherein aportion of said distal end of said wire is formed into a graspingmechanism; a handle positioned at said proximal end of said catheter;and an elongate tube having a proximal end, a distal end, and a firstlumen within wherein said tube is positioned coaxially over saidcatheter, wherein said grasping mechanism is configured to grasp saidporous structure and said elongate tube is configured to receive saidporous structure at its distal end.

The handle may comprise first and second handle components wherein saidfirst and second handle components are disassembled to allow for slidingof said elongate tube onto or off of said catheter. Optionally, saidfirst and second handle components are assembled and held together usinga screw.

The elongate tube may further comprise an adapter at its proximal endwherein said adapter is configured to attach to said second handlecomponent.

Optionally, the elongate tube further comprises: an inflatable balloonpositioned at said distal end of said elongate tube; an insufflationport positioned at said proximal end of said elongate tube; a separate,second lumen in fluid communication with said inflatable balloon andsaid insufflation port; and a compartment positioned at said distal endof said elongate tube configured to contain said balloon when saidballoon is deflated, wherein said balloon is inflatable via saidinsufflation port and said second lumen and said balloon, when inflated,is used to assist in compression of said porous structure into itspre-deployment configuration.

Optionally, the elongate tube further comprises an instillation port atits proximal end for instillation of a cold fluid into said first lumenof said elongate tube wherein said porous structure is comprised of atemperature sensitive material and said cold fluid is used to assist incompression of said porous structure into its pre-deploymentconfiguration.

The catheter further may comprise a sheath for restraining said graspingmechanism. Optionally, the grasping mechanism comprises a hook.

The present specification also discloses a method of retrieving anintragastric device from a gastrointestinal tract of a patient using aretrieval device, wherein said intragastric device comprises a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and includes an elongatesleeve coupled to a distal end of said porous structure and saidretrieval device comprises a flexible catheter having a proximal end, adistal end, and a lumen within, an elongate wire positioned within saidlumen of said catheter and having a proximal end and a distal endwherein a portion of said distal end of said wire is formed into agrasping mechanism, a handle positioned at said proximal end of saidcatheter, and an elongate tube having a proximal end, a distal end, anda first lumen within wherein said tube is positioned coaxially over saidcatheter, said method comprising the steps of: inserting said catheterinto a working channel of an endoscope that has been inserted into saidpatient; positioning a distal end of said endoscope proximate in astomach of said patient, proximate said intragastric device;manipulating said elongate wire to extend said grasping mechanism beyondsaid distal end of said catheter and grasping said porous structure withsaid grasping mechanism; removing said handle from said catheter;sliding said elongate tube over said catheter; replacing said handle;pulling on said elongate wire to pull said porous structure into saidelongate tube; and removing said retrieval device, with saidintragastric device therein, from said patient.

The elongate tube may further comprise an inflatable balloon positionedat said distal end of said elongate tube, an insufflation portpositioned at said proximal end of said elongate tube, a separate,second lumen in fluid communication with said inflatable balloon andsaid insufflation port, and a compartment positioned at said distal endof said elongate tube configured to contain said balloon when saidballoon is deflated, and said method may further comprises the step ofinflating said balloon via said insufflation port and said second lumen,wherein said inflated balloon extends from said compartment and is usedto assist in compression of said porous structure into itspre-deployment configuration.

Optionally, the elongate tube further comprises an instillation port atits proximal end for instillation of a cold fluid into said first lumenof said elongate tube wherein said porous structure is comprised of atemperature sensitive material, said method further comprising the stepof instilling a cold fluid into said first lumen to assist incompression of said porous structure into its pre-deploymentconfiguration.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, wherein said porous structure further comprises: a wiremesh having a substantially spherical post-deployment shape andincluding at least a first plurality of nodes at said top, a secondplurality of nodes at said bottom, and a third plurality of nodespositioned at a lateral location between said top and said bottom,wherein each node comprises a single unsupported free end or bend in awire of said wire mesh; and a collar positioned at said bottom of saidporous structure, said collar having a bend wherein said bend comprisesan extension of said wire curving in a direction away from alongitudinal center axis of said porous structure and then in adirection upward toward said top of said porous structure; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidproximal end of said sleeve is coupled to said second plurality of nodesof said porous structure such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening.

Optionally, said proximal end of said sleeve is coupled to said collar.

Each of said plurality of nodes may comprise 10 to 100 individual nodes.Optionally, each of said plurality of nodes comprises 44 nodes.Optionally, each of said plurality of nodes comprises 36 nodes.

The porous structure has a length and said porous structure may include2 to 60 pluralities of nodes distributed latitudinally at differentlocations along said length. At least 10% of the total number of nodesin said porous structure may be positioned at said top and said bottom.Optionally, no more than 75% of a total number of nodes are positionedin any one of said plurality of nodes.

The wire mesh may be composed of a shape memory metal.

The wire has a wire thickness and said bend of said collar has a bendradius wherein said bend, when said collar is folded in a distaldirection as said porous structure is compressed to said pre-deploymentshape, may be defined by a bending strain percentage equal to two timessaid thickness divided by said radius multiplied by 100. Optionally, thebending strain percentage is in a range of 0.1 to 20%. Optionally, thebending strain percentage is no more than 8%.

Optionally, said thickness is in a range of 0.1 to 1 mm. Optionally,said bend radius is in a range of 0.013 to 20 cm.

The thickness and bend radius may be configured such that two times saidthickness is less than said radius which is less than 2000 times saidthickness.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, wherein said porous structure further comprises: a wiremesh having a substantially spherical post-deployment shape andincluding at least a first plurality of nodes at said top, a secondplurality of nodes at said bottom, and a third plurality of nodespositioned at a lateral location between said top and said bottom,wherein each node comprises a single unsupported free end or bend in awire of said wire mesh; and a collar positioned at said bottom of saidporous structure, said collar having a bend wherein said bend comprisesan extension of said wire curving in a direction away from alongitudinal center axis of said porous structure and then in adirection upward toward said top of said porous structure and whereinsaid wire has a wire thickness and said bend of said collar has a bendradius and wherein said bend, when said collar is folded in a distaldirection as said porous structure is compressed to said pre-deploymentshape, is defined by a bending strain percentage equal to two times saidthickness divided by said radius multiplied by 100, further wherein saidbending strain percentage is in a range of 0.1 to 20%; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidproximal end of said sleeve is coupled to said second plurality of nodesof said porous structure such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening.

Optionally, said bending strain percentage is no more than 8%.Optionally, said thickness is in a range of 0.1 to 1 mm. Optionally,said bend radius is in a range of 0.013 to 20 cm.

The thickness and bend radius may be configured such that two times saidthickness is less than said radius which is less than 2000 times saidthickness.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, wherein said porous structure further comprises: a wiremesh having a substantially spherical post-deployment shape andincluding at least a first plurality of nodes at said top, a secondplurality of nodes at said bottom, and a third plurality of nodespositioned at a lateral location between said top and said bottom,wherein each node comprises a single unsupported free end or bend in awire of said wire mesh and wherein each plurality of nodes includes nomore than 44 individual nodes; and a collar positioned at said bottom ofsaid porous structure, said collar having a bend wherein said bendcomprises an extension of said wire curving in a direction away from alongitudinal center axis of said porous structure and then in adirection upward toward said top of said porous structure and whereinsaid wire has a wire thickness and said bend of said collar has a bendradius and wherein said bend, when said collar is folded in a distaldirection as said porous structure is compressed to said pre-deploymentshape, is defined by a bending strain percentage equal to two times saidthickness divided by said radius multiplied by 100, further wherein saidbending strain percentage is in a range of 0.1 to 20%; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidproximal end of said sleeve is coupled to said second plurality of nodesof said porous structure such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening; and a sleeve having a flexible elongate body, a proximalend with a third opening, a distal end with a fourth opening, and asleeve interior, and having a pre-deployment shape with a first lengthand a post-deployment shape with a second length greater than said firstlength, wherein said proximal end of said sleeve is coupled to saidbottom of said porous structure such that, when sleeve is in saidpost-deployment shape, food exiting said at least one second openingenters said sleeve through said third opening, passes through saidsleeve interior, and exits said sleeve through said fourth opening,wherein said sleeve further comprises at least one helical wireextending along said elongate body configured to provide support to saidsleeve when in said post-deployment shape and wherein said helical wirehas a strain percentage defined by a thickness of said wire and a pitchof said wire, further wherein said pitch is defined by the distancebetween any two points along said wire lying within the same plane alonga longitudinal axis of said sleeve.

The helical wire may be composed of a shape memory metal. Optionally,the shape memory metal is Nitinol.

The helical wire, when compressed as the sleeve is compressed and foldedto its pre-deployment shape, may have a strain percentage in a range of0.1 to 20%. Optionally, the helical wire, when compressed as the sleeveis compressed and folded to its pre-deployment shape, has a strainpercentage of no more than 8%. The pitch may have a range of 5 to 150mm. Optionally, the pitch is equal to 60 mm.

The sleeve may have a length in a range of 1 cm-120 cm and may beconfigured to pass atraumatically into and out of a pylorus of apatient.

The sleeve may be substantially funnel shaped and have a diameter whichdecreases as said sleeve extends from said proximal end to said distalend.

Optionally, a proximal portion of said sleeve is funnel shaped whereinsaid proximal end of said sleeve has a diameter greater than a diameteralong any other portion of said sleeve body and said proximal enddiameter decreases gradually as said sleeve body extends distally.

Optionally, a distal portion of said sleeve body includes two or morelayers configured to reinforce said distal portion and maintain saidsleeve body in an elongate shape when in said post-deployment shape.

Optionally, the sleeve comprises a proximal portion and a distal portionwherein said proximal portion extends from said proximal end of saidsleeve to a transition point on said sleeve body and said distal portionextends from said transition point to said distal end of said sleeve,further wherein said proximal portion is funnel shaped and has adiameter that decreases as said proximal portion extends from saidproximal end of said sleeve to said transition point. Still optionally,said distal portion is funnel shaped and has a diameter that decreasesas said distal portion extends from said transition point to said distalend of said sleeve. Alternatively, said distal portion is cylindershaped and has a diameter that remains constant as said distal portionextends from said transition point to said distal end of said sleeve.Optionally, the diameter of said distal portion increases as said distalportion extends from said transition point to said distal end of saidsleeve.

The sleeve may be comprised of at least one layer of any one orcombination of polytetrafluoroethylene (PTFE), polyethylene (PE),low-density polyethylene (LDPE), high-density polyethylene (HDPE), andultra-high-molecular-weight polyethylene (UHMWPE). Optionally, thesleeve comprises at least two layers of any one or combination ofpolytetrafluoroethylene (PTFE), polyethylene (PE), low-densitypolyethylene (LDPE), high-density polyethylene (HDPE), andultra-high-molecular-weight polyethylene (UHMWPE) and further comprisingat least one metal wire support positioned between said layers.

Optionally, the intragastric device further comprises a componentattached to said distal end of said sleeve and configured to make saiddistal end atraumatic to body tissues, wherein said component comprisesa cylindrical body, a proximal end, a distal end, and a lumen within andwherein said component is open at both ends and said lumen of saidcomponent is in fluid communication with said sleeve interior, furtherwherein an outer surface of said component includes a groove and acircular member positioned within said groove and said component isattached to said sleeve by positioning a portion of said sleeve withinsaid groove and beneath said circular member.

Optionally, said component further includes a flange extending from saidouter surface wherein said flange covers a free end of said distal endof said sleeve. Alternatively, said component further includes a heatshrink tube positioned over said circular member and groove. Stilloptionally, distal end of said sleeve is folded beneath said circularmember such that a free end of said distal end of said sleeve becomespositioned within said sleeve interior.

Optionally, the intragastric device further comprises at least one tailextending from said distal end of said sleeve wherein said tail isconfigured to pull on said sleeve in a distal direction to assist inproper orientation of said sleeve within a patient's gastrointestinaltract.

The distal portion of said sleeve may comprise a plurality of sleevefringes wherein said fringes are attached to a member at said distal endof said sleeve, further wherein said member is configured to pull onsaid sleeve in a distal direction to assist in proper orientation ofsaid sleeve within a patient's gastrointestinal tract. Optionally, thefringes and distal member are parachute shaped.

The distal end of said sleeve may include a plurality of sutures eachhaving a proximal end and a distal end wherein said proximal ends ofsaid sutures are attached to said distal end of said sleeve and saiddistal end of said sutures are attached to a member configured to pullon said sleeve in a distal direction to assist in proper orientation ofsaid sleeve within a patient's gastrointestinal tract. Optionally, thefringes and distal member are parachute shaped.

The distal end of said sleeve may include a plurality of sutures eachhaving a proximal end and a distal end and wherein said proximal ends ofsaid sutures are attached to said distal end of said sleeve and saiddistal end of said sutures are each attached to an individual memberwherein each individual member is configured to pull on said sleeve in adistal direction to assist in proper orientation of said sleeve within apatient's gastrointestinal tract.

Optionally, said sleeve is folded about itself at least once along alongitudinal axis of said sleeve to provide said sleeve with addedstructure.

The sleeve may include at least one channel extending along alongitudinal axis of said sleeve wherein said at least one channelreceives a support member to provide said sleeve with added structure.

At least a portion of said sleeve may have a corrugated structurecomprised of alternating grooves and ridges to provide said sleeve withadded structure.

At least a portion of said sleeve may comprise a flexible wireconfigured into a knitted structure to provide said sleeve with addedstructure.

The sleeve may include at least one channel extending along alongitudinal axis of said sleeve wherein said at least one channel inconfigured to receive a fluid to provide said sleeve with addedstructure.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening; and a sleeve having a flexible elongate body, a proximalend with a third opening, a distal end with a fourth opening, and asleeve interior, and having a pre-deployment shape with a first lengthand a post-deployment shape with a second length greater than said firstlength, wherein said proximal end of said sleeve is coupled to saidbottom of said porous structure such that, when sleeve is in saidpost-deployment shape, food exiting said at least one second openingenters said sleeve through said third opening, passes through saidsleeve interior, and exits said sleeve through said fourth opening,wherein said sleeve further comprises three helical wires extendingalong said elongate body configured to provide support to said sleevewhen in said post-deployment shape and wherein each of said helicalwires has an individual strain percentage defined by a thickness of saidindividual wire and an individual pitch of said individual wire, furtherwherein said individual pitch is defined by the distance between any twopoints along said individual wire lying within the same plane along alongitudinal axis of said sleeve.

Each of said helical wires may be composed of a shape memory metal.Optionally, the shape memory metal is Nitinol.

Each of said helical wires, when compressed as the sleeve is compressedand folded to its pre-deployment shape, may have an individual strainpercentage in a range of 0.1 to 20%. Optionally, each of said helicalwires, when compressed as sleeve is compressed and folded to itspre-deployment shape, has an individual strain percentage of no morethan 8%.

The individual pitch of each of said helical wires may have a range of 5to 150 mm. Optionally, the individual pitch of each of said helicalwires is equal to 60 mm.

Optionally, each of said wires includes an adjacent wire pitch definedas the distance between any two points along two adjacent wires lyingwithin the same plane along a longitudinal axis of said sleeve whereinsaid adjacent wire pitch is equal to 20 mm.

Optionally, a proximal portion of said sleeve is funnel shaped whereinsaid proximal end of said sleeve has a diameter greater than a diameteralong any other portion of said sleeve body and said proximal enddiameter decreases gradually as said sleeve body extends distally.

Optionally, a distal portion of said sleeve body includes two or morelayers configured to reinforce said distal portion and maintain saidsleeve body in an elongate shape when in said post-deployment shape.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening; and a sleeve having a flexible elongate body, a proximalend with a third opening, a distal end with a fourth opening, and asleeve interior, and having a pre-deployment shape with a first lengthand a post-deployment shape with a second length greater than said firstlength, wherein said proximal end of said sleeve is coupled to saidbottom of said porous structure such that, when sleeve is in saidpost-deployment shape, food exiting said at least one second openingenters said sleeve through said third opening, passes through saidsleeve interior, and exits said sleeve through said fourth opening,wherein said sleeve further comprises at least one helical wireextending along said elongate body configured to provide support to saidsleeve when in said post-deployment shape and wherein said helical wirehas a strain percentage defined by a thickness of said wire and a pitchof said wire wherein said sleeve is foldable upon itself at least fivetimes such that said strain percentage will not exceed 20%, furtherwherein said pitch is defined by the distance between any two pointsalong said wire lying within the same plane along a longitudinal axis ofsaid sleeve.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, wherein said porous structure further comprises: a wiremesh having a substantially spherical post-deployment shape andincluding at least a first plurality of nodes at said top, a secondplurality of nodes at said bottom, and a third plurality of nodespositioned at a lateral location between said top and said bottom,wherein each node comprises a single unsupported free end or bend in awire of said wire mesh; and a collar positioned at said bottom of saidporous structure, said collar having a bend wherein said bend comprisesan extension of said wire curving in a direction away from alongitudinal center axis of said porous structure and then in adirection upward toward said top of said porous structure; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidproximal end of said sleeve is coupled to said second plurality of nodesof said porous structure such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening,wherein at least a portion of a total number of nodes in said secondplurality of nodes is coupled to said proximal end of said sleeve bysutures.

Each node of said portion of said total number of nodes in said secondplurality of nodes may be sutured to said proximal end of said sleeve ata most distal position on each node. Optionally, the portion of saidtotal number of nodes in said second plurality of nodes comprises all ofsaid nodes within said second plurality of nodes. Optionally, theportion of said total number of nodes in said second plurality of nodescomprises every other node within said second plurality of nodes.

The sutures may be applied loosely to allow for some relative movementbetween said wire mesh and said sleeve.

Each suture coupling said sleeve to each of said nodes of said portionof said total number of nodes in said second plurality of nodes maycomprise only one knot.

The wire of said wire mesh may include at least two ends wherein saidends are joined and crimped together using a metal tube.

The wire of said wire mesh may include at least two ends wherein saidends are looped back onto said wire to create atraumatic wire ends orlooped outward to create attachment points to said sleeve.

The sleeve may include a wire for support and said wire may include atleast two ends wherein said ends are looped back onto said wire tocreate atraumatic wire ends, looped outward to create attachment pointsfor coupling to said wire mesh or are used to pull on said sleeve duringcompression of said device.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, wherein said porous structure further comprises: a wiremesh having a substantially spherical post-deployment shape andincluding at least a first plurality of nodes at said top, a secondplurality of nodes at said bottom, and a third plurality of nodespositioned at a lateral location between said top and said bottom,wherein each node comprises a single unsupported free end or bend in awire of said wire mesh; and a collar positioned at said bottom of saidporous structure, said collar having a bend wherein said bend comprisesan extension of said wire curving in a direction away from alongitudinal center axis of said porous structure and then in adirection upward toward said top of said porous structure; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidproximal end of said sleeve is coupled to said second plurality of nodesof said porous structure such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening,wherein a portion of said wire proximal to each node crosses withanother portion of wire proximal an adjacent node to create anintersection and wherein at least a portion of a total number of saidintersections at said bottom of said porous structure is coupled to saidproximal end of said sleeve by sutures.

Optionally, the portion of said total number of said intersections atsaid bottom of said porous structure comprises all of said intersectionsproximate said bottom of said porous structure. Optionally, the portionof said total number of said intersections at said bottom of said porousstructure comprises every other intersection proximate said bottom ofsaid porous structure.

The sutures may be applied loosely to allow for some relative movementbetween said wire mesh and said sleeve.

Each suture coupling said sleeve to each of said intersections of saidportion of said total number of intersections proximate said bottom ofsaid porous structure may comprise only one knot.

The wire of said wire mesh may include at least two ends wherein saidends are joined and crimped together using a metal tube.

The wire of said wire mesh may include at least two ends wherein saidends are looped back onto said wire to create atraumatic wire ends orlooped outward to create attachment points to said sleeve.

The sleeve may include a wire for support and said wire may include atleast two ends wherein said ends are looped back onto said wire tocreate atraumatic wire ends, looped outward to create attachment pointsfor coupling to said wire mesh or are used to pull on said sleeve duringcompression of said device.

The present specification also discloses a method for compressing anintragastric device for loading onto a delivery device prior todeployment, said intragastric device comprising a porous structurecomprising a top, a bottom, and an interior and having a pre-deploymentshape with a first volume and a post-deployment shape with a secondvolume greater than said first volume, wherein, in said post-deploymentshape, said porous structure includes at least one first openingproximate said top and at least one second opening proximate said bottomsuch that food enters said porous structure through said at least onefirst opening, passes through said interior, and exits said porousstructure through said at least one second opening, wherein said porousstructure further comprises a wire mesh having a substantially sphericalpost-deployment shape and including at least a first plurality of nodesat said top, a second plurality of nodes at said bottom, and a thirdplurality of nodes positioned at a lateral location between said top andsaid bottom, wherein each node comprises a single unsupported free endor bend in a wire of said wire mesh; and a collar positioned at saidbottom of said porous structure, said collar having a bend wherein saidbend comprises an extension of said wire curving in a direction awayfrom a longitudinal center axis of said porous structure and then in adirection upward toward said top of said porous structure; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidproximal end of said sleeve is coupled to said second plurality of nodesof said porous structure such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening,wherein at least a portion of a total number of nodes in said secondplurality of nodes is coupled to said proximal end of said sleeve bysutures, said method comprising the steps of: compressing said wire meshabout a longitudinal center axis of said porous structure; and pullingon said distal end of said sleeve, causing said bend of said collar tocurve in a downward direction such that said collar becomessubstantially straightened.

The sutures may be applied loosely to allow for some relative movementbetween said wire mesh and said sleeve.

The sleeve may include a wire for support and said wire may include atleast two ends wherein said ends are looped back onto said wire tocreate atraumatic wire ends, looped outward to create attachment pointsfor coupling to said wire mesh or are used to pull on said sleeve duringcompression of said device.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening; and a sleeve having a flexible elongate body, a proximalend with a third opening, a distal end with a fourth opening, and asleeve interior, and having a pre-deployment shape with a first lengthand a post-deployment shape with a second length greater than said firstlength, wherein said proximal end of said sleeve is coupled to saidbottom of said porous structure such that, when sleeve is in saidpost-deployment shape, food exiting said at least one second openingenters said sleeve through said third opening, passes through saidsleeve interior, and exits said sleeve through said fourth opening,wherein said sleeve has a coefficient of friction which allows saidsleeve to at least be folded upon itself, wrapped about a portion of adeployment device, pulled back and forth during deployment, and deployedfully without any structural damage to said sleeve.

The coefficient of friction may be in a range of 0.01-0.45. Optionally,the coefficient of friction is equal to or less than 0.10.

The sleeve has an outer surface and wherein said outer surface may be amatte surface. A particulate matter may be applied to an outer surfaceof said sleeve. Optionally, the particulate matter is corn starch.Optionally, the particulate matter is a biocompatible powder.

The sleeve may be folded upon itself at least 2 times.

The present specification also discloses a method of delivering anintragastric device in a gastrointestinal tract of a patient, saidintragastric device comprising a porous structure comprising a top, abottom, and an interior and having a pre-deployment shape with a firstvolume and a post-deployment shape with a second volume greater thansaid first volume, wherein, in said post-deployment shape, said porousstructure includes at least one first opening proximate said top and atleast one second opening proximate said bottom such that food enterssaid porous structure through said at least one first opening, passesthrough said interior, and exits said porous structure through said atleast one second opening and a sleeve having a flexible elongate body, aproximal end with a third opening, a distal end with a fourth opening,and a sleeve interior, and having a pre-deployment shape with a firstlength and a post-deployment shape with a second length greater thansaid first length, wherein said proximal end of said sleeve is coupledto said bottom of said porous structure such that, when sleeve is insaid post-deployment shape, food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening,wherein said sleeve has a coefficient of friction which allows saidsleeve to at least be folded upon itself, wrapped about a portion of adeployment device, pulled back and forth during deployment, and deployedfully without any structural damage to said sleeve, said methodcomprising the steps of: loading said porous structure onto a deliverydevice; folding said sleeve upon itself; wrapping said folded sleeveabout a portion of said delivery device; inserting said delivery device,including said porous structure and said sleeve, into saidgastrointestinal tract of said patient; manipulating said deliverydevice to fully deploy said sleeve; further manipulating said deliverydevice to fully deploy said porous structure; and removing said deliverydevice from said patient.

The coefficient of friction may be in a range of 0.01-0.45.

The method may further comprise the step of applying a particulatematter to an outer surface of said sleeve prior to folding said sleeveupon itself. Optionally, the particulate matter is corn starch.Optionally, the particulate matter is a biocompatible powder.

The sleeve may be folded upon itself at least 2 times.

The present specification also discloses a method of delivering anintragastric device in a gastrointestinal tract of a patient, saidintragastric device comprising a porous structure comprising a top, abottom, and an interior and having a pre-deployment shape with a firstvolume and a post-deployment shape with a second volume greater thansaid first volume, wherein, in said post-deployment shape, said porousstructure includes at least one first opening proximate said top and atleast one second opening proximate said bottom such that food enterssaid porous structure through said at least one first opening, passesthrough said interior, and exits said porous structure through said atleast one second opening and a sleeve having a flexible elongate body, aproximal end with a third opening, a distal end with a fourth opening,and a sleeve interior, and having a pre-deployment shape with a firstlength and a post-deployment shape with a second length greater thansaid first length, wherein said proximal end of said sleeve is coupledto said bottom of said porous structure such that, when sleeve is insaid post-deployment shape, food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth opening,wherein said sleeve has a coefficient of friction which allows saidsleeve to at least be folded upon itself, wrapped about a portion of adeployment device, pulled back and forth during deployment, and deployedfully without any structural damage to said sleeve, said methodcomprising the steps of: loading said porous structure onto a deliverydevice; folding said sleeve upon itself; wrapping said folded sleeveabout a portion of said delivery device; inserting said delivery device,including said porous structure and said sleeve, into saidgastrointestinal tract of said patient; manipulating said deliverydevice to partially deploy said sleeve, wherein said sleeve is releasedfully from said delivery device but only partially unfurls from saidfolding; further manipulating said delivery device to fully deploy saidporous structure; removing said delivery device from said patient; andallowing said sleeve to fully unfurl through the actions of peristalticintestinal contractions upon said sleeve.

The coefficient of friction may be in a range of 0.01-0.45.

The method may further comprise the step of applying a particulatematter to an outer surface of said sleeve prior to folding said sleeveupon itself. Optionally, the particulate matter is corn starch.Optionally, the particulate matter is a biocompatible powder.

The sleeve may be folded upon itself at least 2 times.

The present specification also discloses a delivery device fordelivering an intragastric device into a gastrointestinal tract of apatient, said intragastric device comprising a porous structureconfigurable between a compressed pre-deployment configuration and anexpanded post-deployment configuration and an elongate sleeve coupled toa distal end of said porous structure, said delivery device comprising:a flexible elongate body with a proximal end, a distal end, and a bodylumen within, said body comprising an opening at said distal end and afirst handle attached to said proximal end; a flexible plunger componentpositioned coaxially, and movable longitudinally, within the lumen ofsaid body, said plunger including a proximal end, a distal end, and aplunger lumen within and comprising a tip at said distal end and asecond handle attached to said proximal end; a flexible elongate rodpositioned coaxially, and movable longitudinally, within said plungerlumen, said rod including a proximal end and a distal end and comprisinga first spherical component positioned proximal to said distal end and asecond spherical component positioned at said distal end wherein saidfirst spherical component has a diameter greater than a diameter of saidsecond spherical component, said rod further comprising a third handleattached to said proximal end; and a pulling mechanism comprising afirst end and a second end wherein said first end is attached to saidsleeve of said intragastric device and said second end is removablycoupled to said rod at a position between said first spherical componentand said second spherical component, wherein said intragastric device isloaded for delivery within said delivery device such that: said porousstructure is positioned within said body lumen distal to said plungertip and proximal to said sleeve and wherein said rod passes through atleast two openings in said porous structure and wherein said at leasttwo openings do not lie along a center longitudinal axis of said porousstructure; said sleeve is positioned within said body lumen distal tosaid porous structure and proximal to said first spherical component andwherein said sleeve is folded upon itself and then wrapped about aportion of said rod, further wherein said sleeve is attached to saidfirst end of said pulling mechanism.

The delivery device may further comprise a stopper positioned on saidplunger between said tip and said second handle.

Optionally, the said pulling mechanism is biodegradable and comprises asuture or a hook. Alternatively, said pulling mechanism isnon-biodegradable and comprises a suture with a loop end.

Optionally, the said sleeve is constrained by a ring, cone, or umbrellashaped constraining device.

Optionally, said tip of said plunger includes a mesh retention componentcomprising a plurality of fins wherein a proximal portion of said porousstructure is positioned over said fins such that said fins cause saidporous structure to move in a proximal direction when said plunger ismoved in a proximal direction.

The sleeve may be folded upon itself two to ten times before beingwrapped about said rod.

The delivery device may further comprise an inflatable balloon at saiddistal end of said body, an input port at said proximal end of saidbody, and a channel extending along said elongate body and in fluidcommunication with said balloon and said port, wherein said balloon isinflated using said port and said channel and said inflated balloon isused to anchor said delivery device within said gastrointestinal tractof said patient.

Optionally, the delivery device further comprises a flushing orirrigation mechanism to reduce deployment forces during delivery.

The elongate body includes a length and said length may include avariable stiffness. Optionally, the length includes at least three zonesand a most distal zone is more flexible than a center distal zone, whichis more flexible than a least distal zone.

The elongate body may comprise a braided catheter.

The distal ends of the elongate body, plunger, and rod may be configuredto be atraumatic.

The present specification also discloses a delivery device fordelivering an intragastric device into a gastrointestinal tract of apatient, said intragastric device comprising a porous structureconfigurable between a compressed pre-deployment configuration and anexpanded post-deployment configuration and an elongate sleeve coupled toa distal end of said porous structure, said delivery device comprising:a flexible elongate body with a proximal end, a distal end, and a bodylumen within, said body comprising an opening at said distal end and anactuating mechanism attached to said proximal end; a flexible plungercomponent positioned coaxially, and movable longitudinally, within thelumen of said body, said plunger including a proximal end, a distal end,and a plunger lumen within and comprising a tip at said distal end andwherein said proximal end is operatively attached to said actuatingmechanism; an actuator handle and an actuator trigger attached to saidactuating mechanism and configured, when operated, to cause saidactuating mechanism to move said plunger back and forth in alongitudinal direction relative to said elongate body; a flexibleelongate rod positioned coaxially, and movable longitudinally, withinsaid plunger lumen, said rod including a proximal end and a distal endand comprising a first spherical component positioned proximal to saiddistal end and a second spherical component positioned at said distalend wherein said first spherical component has a diameter greater than adiameter of said second spherical component, said rod further comprisinga rod handle attached to said proximal end; and a pulling mechanismcomprising a first end and a second end wherein said first end isattached to said sleeve of said intragastric device and said second endis removably coupled to said rod at a position between said firstspherical component and said second spherical component, wherein saidintragastric device is loaded for delivery within said delivery devicesuch that: said porous structure is positioned within said body lumendistal to said plunger tip and proximal to said sleeve and wherein saidrod passes through at least two openings in said porous structure andwherein said at least two openings do not lie along a centerlongitudinal axis of said porous structure; said sleeve is positionedwithin said body lumen distal to said porous structure and proximal tosaid first spherical component and wherein said sleeve is folded uponitself and then wrapped about a portion of said rod, further whereinsaid sleeve is attached to said first end of said pulling mechanism.

The delivery device may further comprise a stopper positioned on saidplunger between said tip and said actuating mechanism.

Optionally, the pulling mechanism is biodegradable and comprises asuture or a hook. Alternatively, said pulling mechanism isnon-biodegradable and comprises a suture with a loop end.

Optionally, the sleeve is constrained by a ring, cone, or umbrellashaped constraining device.

Optionally, said tip of said plunger includes a mesh retention componentcomprising a plurality of fins wherein a proximal portion of said porousstructure is positioned over said fins such that said fins cause saidporous structure to move in a proximal direction when said plunger ismoved in a proximal direction.

The sleeve may be folded upon itself two to ten times before beingwrapped about said rod.

The delivery device may further comprise an inflatable balloon at saiddistal end of said body, an input port at said proximal end of saidbody, and a channel extending along said elongate body and in fluidcommunication with said balloon and said port, wherein said balloon isinflated using said port and said channel and said inflated balloon isused to anchor said delivery device within said gastrointestinal tractof said patient.

Optionally, the delivery device further comprises a flushing orirrigation mechanism to reduce deployment forces during delivery.

The elongate body may comprise a braided catheter.

The present specification also discloses a method of delivering anintragastric device into a gastrointestinal tract of a patient, saidintragastric device comprising a porous structure configurable between acompressed pre-deployment configuration and an expanded post-deploymentconfiguration and an elongate sleeve coupled to a distal end of saidporous structure, said delivery device comprising a flexible elongatebody with a proximal end, a distal end, and a body lumen within, saidbody comprising an opening at said distal end and a first handleattached to said proximal end, a flexible plunger component positionedcoaxially, and movable longitudinally, within the lumen of said body,said plunger including a proximal end, a distal end, and a plunger lumenwithin and comprising a tip at said distal end and a second handleattached to said proximal end, a flexible elongate rod positionedcoaxially, and movable longitudinally, within said plunger lumen, saidrod including a proximal end and a distal end and comprising a firstspherical component positioned proximal to said distal end and a secondspherical component positioned at said distal end wherein said firstspherical component has a diameter greater than a diameter of saidsecond spherical component, said rod further comprising a third handleattached to said proximal end, and a pulling mechanism comprising afirst end and a second end wherein said first end is attached to saidsleeve of said intragastric device and said second end is removablycoupled to said rod at a position between said first spherical componentand said second spherical component, wherein said intragastric device isloaded for delivery within said delivery device such that said porousstructure is positioned within said body lumen distal to said plungertip and proximal to said sleeve and wherein said rod passes through atleast two openings in said porous structure and wherein said at leasttwo openings do not lie along a center longitudinal axis of said porousstructure said sleeve is positioned within said body lumen distal tosaid porous structure and proximal to said first spherical component andwherein said sleeve is folded upon itself and then wrapped about aportion of said rod, further wherein said sleeve is attached to saidfirst end of said pulling mechanism, said method comprising the stepsof: sliding said delivery device over a guidewire into saidgastrointestinal tract of said patient; using the first handle,positioning the distal end of said elongate body in a duodenum of thepatient; pushing the second handle to push in the plunger componentuntil the sleeve is pushed out of said elongate body; pushing the thirdhandle to advance the rod within the plunger lumen until the sleeve isfully deployed; pulling said delivery device back to reposition thedistal end of the elongate body within a stomach of the patient; pullingback on the first handle while holding the second handle steady, keepingthe plunger in place and releasing the wire mesh structure; and removingthe delivery device from the patient.

The delivery device may further comprise a stopper positioned on saidplunger between said tip and said second handle wherein said stopper isconfigured to stop further distal movement of said plunger once saidsleeve has been pushed out of said elongate body.

The delivery device may further comprise an inflatable balloon at saiddistal end of said body, an input port at said proximal end of saidbody, and a channel extending along said elongate body and in fluidcommunication with said balloon and said port, and said method mayfurther comprise the step of using said port and said channel to inflatesaid balloon to anchor the delivery device in the gastrointestinal tractof said patient.

The present specification also discloses a delivery device fordelivering an intragastric device into a gastrointestinal tract of apatient, said intragastric device comprising a porous structureconfigurable between a compressed pre-deployment configuration and anexpanded post-deployment configuration and an elongate sleeve coupled toa distal end of said porous structure, said delivery device comprising:a flexible elongate body with a proximal end, a distal end, and a bodylumen within, said body comprising an opening at said distal end and afirst handle attached to said proximal end; a flexible elongate rodpositioned coaxially, and movable longitudinally, within said bodylumen, said rod including a proximal end and a distal end and comprisinga first spherical component positioned proximal to said distal end and asecond spherical component positioned at said distal end wherein saidfirst spherical component has a diameter greater than a diameter of saidsecond spherical component, said rod further comprising a second handleattached to said proximal end; a flexible plunger component positionedcoaxially over a proximal portion of, and movable longitudinally with,said flexible elongate rod, said plunger including a proximal end and adistal end and comprising a tip at said distal end and attached to saidsecond handle at said proximal end; a pulling mechanism comprising afirst end and a second end wherein said first end is attached to saidsleeve of said intragastric device and said second end is removablycoupled to said rod at a position between said first spherical componentand said second spherical component, wherein said intragastric device isloaded for delivery within said delivery device such that: said porousstructure is positioned within said body lumen distal to said plungertip and proximal to said sleeve and wherein said rod passes through atleast two openings in said porous structure and wherein said at leasttwo openings do not lie along a center longitudinal axis of said porousstructure; said sleeve is positioned within said body lumen distal tosaid porous structure and proximal to said first spherical component andwherein said sleeve is folded upon itself and then wrapped about aportion of said rod, further wherein said sleeve is attached to saidfirst end of said pulling mechanism.

The pulling mechanism may be biodegradable and comprise a suture or ahook. Alternatively, said pulling mechanism is non-biodegradable andcomprises a suture with a loop end.

The sleeve may be constrained by a ring, cone, or umbrella shapedconstraining device.

Optionally, said tip of said plunger includes a mesh retention componentcomprising a plurality of fins wherein a proximal portion of said porousstructure is positioned over said fins such that said fins cause saidporous structure to move in a proximal direction when said plunger ismoved in a proximal direction.

Optionally, said sleeve is folded upon itself two to ten times beforebeing wrapped about said rod.

Optionally, the delivery device further comprises an inflatable balloonat said distal end of said body, an input port at said proximal end ofsaid body, and a channel extending along said elongate body and in fluidcommunication with said balloon and said port, wherein said balloon isinflated using said port and said channel and said inflated balloon isused to anchor said delivery device within said gastrointestinal tractof said patient.

Optionally, the delivery device further comprises a flushing orirrigation mechanism to reduce deployment forces during delivery.

The elongate body may include a length wherein said length includes avariable stiffness.

The elongate body may include at least three zones wherein a most distalzone is more flexible than a center distal zone, which is more flexiblethan a least distal zone.

The elongate body may comprise a braided catheter.

The distal ends of the elongate body, plunger, and rod may be configuredto be atraumatic.

The present specification also discloses a method of delivering anintragastric device into a gastrointestinal tract of a patient, saidintragastric device comprising a porous structure configurable between acompressed pre-deployment configuration and an expanded post-deploymentconfiguration and an elongate sleeve coupled to a distal end of saidporous structure, said delivery device comprising a flexible elongatebody with a proximal end, a distal end, and a body lumen within, saidbody comprising an opening at said distal end and a first handleattached to said proximal end, a flexible elongate rod positionedcoaxially, and movable longitudinally, within said body lumen, said rodincluding a proximal end and a distal end and comprising a firstspherical component positioned proximal to said distal end and a secondspherical component positioned at said distal end wherein said firstspherical component has a diameter greater than a diameter of saidsecond spherical component, said rod further comprising a second handleattached to said proximal end, a flexible plunger component positionedcoaxially over a proximal portion of, and movable longitudinally with,said flexible elongate rod, said plunger including a proximal end and adistal end and comprising a tip at said distal end and attached to saidsecond handle at said proximal end, a pulling mechanism comprising afirst end and a second end wherein said first end is attached to saidsleeve of said intragastric device and said second end is removablycoupled to said rod at a position between said first spherical componentand said second spherical component, wherein said intragastric device isloaded for delivery within said delivery device such that said porousstructure is positioned within said body lumen distal to said plungertip and proximal to said sleeve and wherein said rod passes through atleast two openings in said porous structure and wherein said at leasttwo openings do not lie along a center longitudinal axis of said porousstructure, wherein said sleeve is positioned within said body lumendistal to said porous structure and proximal to said first sphericalcomponent and wherein said sleeve is folded upon itself and then wrappedabout a portion of said rod, further wherein said sleeve is attached tosaid first end of said pulling mechanism, said method comprising thesteps of: sliding said delivery device over a guidewire into saidgastrointestinal tract of said patient; using the first handle,positioning the distal end of said elongate body in a duodenum of thepatient; pushing the second handle to push in the plunger component androd until the sleeve is fully deployed; pulling said delivery deviceback to reposition the distal end of the elongate body within a stomachof the patient; pulling back on the first handle while holding thesecond handle steady, keeping the plunger and rod in place and releasingthe wire mesh structure; and removing the delivery device from thepatient.

Optionally, said delivery device further comprises a stopper positionedon said plunger between said tip and said second handle wherein saidstopper is configured to stop further distal movement of said plungerand rod once said sleeve has been pushed out of said elongate body.

Optionally, said delivery device further comprises an inflatable balloonat said distal end of said body, an input port at said proximal end ofsaid body, and a channel extending along said elongate body and in fluidcommunication with said balloon and said port, and said method furthercomprises the step of using said port and said channel to inflate saidballoon to anchor the delivery device in the gastrointestinal tract ofsaid patient.

The present specification also discloses a delivery system fordelivering an intragastric device, said delivery system comprising: anouter catheter having a proximal end and a distal end and variablestiffness along its length; and a flexible inner catheter coaxiallypositioned inside the outer catheter and having a proximal end, anatraumatic distal end, and a lumen for receiving a guiding device;wherein said intragastric device is positioned in a space between theinner catheter and the outer catheter and said inner catheter includes aflexible extension having a length of at least 5 cm at its distal endwhich extends beyond said distal end of said outer catheter.

Optionally, the guiding device is a guidewire. Alternatively, theguiding device is an endoscope for over the scope delivery.

The atraumatic distal end may be a ball-tip.

The said inner catheter may have a variable stiffness along its length.

Optionally, said flexible extension includes a proximal end and a distalend and has a variable stiffness along its length wherein the stiffnessvaries between a stiffness of a guidewire at said distal end to astiffness of said inner catheter at said proximal end.

The present specification also discloses an intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, wherein said porous structure further comprises: a wiremesh having a substantially spherical post-deployment shape; and acollar positioned at said bottom of said porous structure, said collarhaving a bend wherein said bend comprises an extension of said wirecurving in a direction away from a longitudinal center axis of saidporous structure and then in a direction upward toward said top of saidporous structure; and a sleeve having a flexible elongate body, aproximal end with a third opening, a distal end with a fourth opening,and a sleeve interior, wherein said proximal end of said sleeve iscoupled to said collar such that food exiting said at least one secondopening enters said sleeve through said third opening, passes throughsaid sleeve interior, and exits said sleeve through said fourth openingwherein the sleeve is designed to intermittently engage a patientspylorus without blocking said pylorus and allows for passage of the foodthrough the said lumen of the sleeve from the stomach into the smallintestine.

The present specification also discloses a system for delivering anintragastric device to a gastrointestinal tract of a patient,comprising: a porous mesh structure having a first lumen; a sleeve bothattached to said porous mesh structure and having a second lumen; acoaxial catheter system comprising an outer catheter and an innercatheter wherein, prior to delivery, said porous mesh structure and saidsleeve are constrained into a space between said outer and innercatheters and wherein the outer catheter covers a substantial portion ofthe intragastric device and the inner catheter passes within a majorityof the first lumen of the mesh but outside of a majority of the secondlumen of the sleeve.

Optionally, said inner catheter is operationally attached to the sleeveat a distal end of said inner catheter such that, when actuated, theinner catheter pushes the sleeve out of the coaxial catheter system andis then detached from the sleeve to deliver the intragastric device inthe gastrointestinal tract.

The present specification also discloses a system for promoting weightloss in a patient, said system comprising an intragastric device, adelivery device, and a retrieval device, wherein said intragastricdevice is configured to be temporarily deployed within agastrointestinal tract of a patient, said intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, said porous structure further comprising a collarpositioned at said bottom of said porous structure, said collar having abend wherein said bend comprises an extension of said porous structurecurving in a direction away from a longitudinal center axis of saidporous structure and then in a direction upward toward said top of saidporous structure; and a sleeve having a flexible elongate body, aproximal end with a third opening, a distal end with a fourth opening,and a sleeve interior, wherein said proximal end of said sleeve iscoupled to said bottom of said porous structure such that food exitingsaid at least one second opening enters said sleeve through said thirdopening, passes through said sleeve interior, and exits said sleevethrough said fourth opening; wherein, once said intragastric device hasbeen deployed in a gastrointestinal tract of said patient, at least aportion of said intragastric device is in constant physical contact witha portion of said gastrointestinal tract of said patient without beingphysically attached to any portion of the anatomy of said patient.

The physical contact may be caused by peristaltic actions of a smallintestine pulling on said sleeve of said intragastric device in saidsmall intestine.

The portion of said intragastric device may comprise a portion of saidporous structure and said portion of said gastrointestinal tract of saidpatient may comprise a portion of a stomach proximate a pylorus.Optionally, the portion of said stomach comprises said gastric emptyingregion of said stomach and said intragastric device does not occludesaid region.

The portion of said intragastric device may comprise a portion of saidsleeve and said portion of said gastrointestinal tract of said patientmay comprise a portion of a pylorus.

The portion of said intragastric device may comprise a portion of saidsleeve and said portion of said gastrointestinal tract of said patientmay comprise a portion of a duodenum.

The intragastric device may direct food through itself, allowing food topass from a stomach of said patient into a small intestine of saidpatient without blocking the passage of said food. Optionally, at least10%, and preferably 50%, of the food passing from a stomach of saidpatient into a small intestine of said patient passes through saidintragastric device.

The intragastric device may provide a constant and substantiallycomplete bypass of a pylorus of said patient. Optionally, theintragastric device provides a constant and substantially completebypass of a pylorus and a duodenum of said patient.

The present specification also discloses a system for promoting weightloss in a patient, said system comprising an intragastric device, adelivery device, and a retrieval device, wherein said intragastricdevice is configured to be temporarily deployed within agastrointestinal tract of a patient, said intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, said porous structure further comprising a collarpositioned at said bottom of said porous structure, said collar having abend wherein said bend comprises an extension of said porous structurecurving in a direction away from a longitudinal center axis of saidporous structure and then in a direction upward toward said top of saidporous structure; and a sleeve having a flexible elongate body, aproximal end with a third opening, a distal end with a fourth opening,and a sleeve interior, wherein said proximal end of said sleeve iscoupled to said bottom of said porous structure such that food exitingsaid at least one second opening enters said sleeve through said thirdopening, passes through said sleeve interior, and exits said sleevethrough said fourth opening; wherein, once said intragastric device hasbeen deployed in a gastrointestinal tract of said patient, said porousstructure is positioned within, and physically contacts a portion of, astomach of said patient and said sleeve is positioned within a pylorusand a duodenum of said patient such that said intragastric deviceprovides a constant and substantially complete bypass of a pylorus ofsaid patient wherein food ingested by said patient is unable tophysically contact any portion of said pylorus.

The physical contact with said portion of said stomach may be caused byperistaltic actions of a small intestine pulling on said sleeve of saidintragastric device in said small intestine.

The intragastric device may direct food through itself, allowing food topass from a stomach of said patient into a small intestine of saidpatient without blocking the passage of said food. Optionally, at least10%, and preferably 50%, of the food passing from a stomach of saidpatient into a small intestine of said patient passes through saidintragastric device.

Optionally, the intragastric device is not physically attached to anyportion of the anatomy of said patient.

The present specification also discloses a system for promoting weightloss in a patient, said system comprising an intragastric device, adelivery device, and a retrieval device, wherein said intragastricdevice is configured to be temporarily deployed within agastrointestinal tract of a patient, said intragastric devicecomprising: a porous structure comprising a top, a bottom, and aninterior and having a pre-deployment shape with a first volume and apost-deployment shape with a second volume greater than said firstvolume, wherein, in said post-deployment shape, said porous structureincludes at least one first opening proximate said top and at least onesecond opening proximate said bottom such that food enters said porousstructure through said at least one first opening, passes through saidinterior, and exits said porous structure through said at least onesecond opening, said porous structure further comprising a collarpositioned at said bottom of said porous structure, said collar having abend wherein said bend comprises an extension of said porous structurecurving in a direction away from a longitudinal center axis of saidporous structure and then in a direction upward toward said top of saidporous structure; and a sleeve having a flexible elongate body, aproximal end with a third opening, a distal end with a fourth opening,and a sleeve interior, wherein said proximal end of said sleeve iscoupled to said bottom of said porous structure such that food exitingsaid at least one second opening enters said sleeve through said thirdopening, passes through said sleeve interior, and exits said sleevethrough said fourth opening; wherein, once said intragastric device hasbeen deployed in a gastrointestinal tract of said patient, said porousstructure is positioned within, and physically contacts a portion of, astomach of said patient and said sleeve is positioned within a pylorusand a duodenum of said patient such that said intragastric deviceprovides a constant and substantially complete bypass of a duodenum ofsaid patient wherein food ingested by said patient is unable tophysically contact any portion of said duodenum.

The system physical contact with said portion of said stomach may becaused by peristaltic actions of a small intestine pulling on saidsleeve of said intragastric device in said small intestine.

The intragastric device may direct food through itself, allowing food topass from a stomach of said patient into a small intestine of saidpatient without blocking the passage of said food. Optionally, at least10%, and preferably 50%, of the food passing from a stomach of saidpatient into a small intestine of said patient passes through saidintragastric device.

Optionally, the intragastric device is not physically attached to anyportion of the anatomy of said patient.

The aforementioned and other embodiments of the present invention shallbe described in greater depth in the drawings and detailed descriptionprovided below.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will beappreciated as they become better understood by reference to thefollowing detailed description when considered in connection with theaccompanying drawings, wherein:

FIG. 1 is an illustration of an upper gastrointestinal system;

FIG. 2A is an illustration of a wire mesh structure in a post-deploymentconfiguration with a proximally sloping anti-migration disc or collarattached to its distal end, in accordance with one embodiment of thepresent specification;

FIG. 2B is an illustration of a wire mesh structure in a post-deploymentconfiguration with a proximally curving anti-migration collar formed atits distal end, in accordance with one embodiment of the presentspecification;

FIGS. 2C and 2D are another illustrations of wire mesh structures, inaccordance with other embodiments of the present specification;

FIG. 2E is an illustration of a wire loop in accordance with at leastone embodiment;

FIG. 2F is a side view of the wire loop of FIG. 2E depicting a thicknessof the loop in accordance with at least one embodiment;

FIG. 2G is an illustration of a wire piece in accordance with at leastone embodiment;

FIG. 2H is an illustration of a width of a gap in the wire meshstructure in accordance with at least one embodiment;

FIG. 3A is an illustration depicting a plurality of free ends or nodespositioned at a proximal end of a wire mesh structure, in accordancewith one embodiment of the present specification;

FIG. 3B is an illustration depicting a plurality of free ends or nodespositioned at a distal end of a wire mesh structure in accordance withat least one embodiment;

FIG. 3C is an illustration depicting a plurality of overlapping nodespositioned at one end of a wire mesh structure, in accordance with oneembodiment of the present specification;

FIG. 3D is an illustration depicting a first plurality of nodespositioned at one end of a wire mesh structure and a second plurality ofnodes positioned proximal to the first plurality of nodes, in accordancewith one embodiment of the present specification;

FIG. 3E is an illustration of first and second pluralities of nodes atan end of a wire mesh structure, depicting loops formed in the wires ofthe first plurality in accordance with one embodiment of the presentspecification;

FIG. 3F is an illustration of first and second pluralities of nodes atan end of a wire mesh structure, depicting loops formed in the wires ofthe second plurality in accordance with one embodiment of the presentspecification;

FIG. 3G is an illustration of first and second pluralities of nodes atan end of a wire mesh structure, depicting loops formed in alternatingwires of both the first and second pluralities, in accordance with oneembodiment of the present specification;

FIG. 3H is an illustration depicting a wire mesh structure having afirst plurality of nodes at its proximal end and a second plurality ofnodes at its distal end, in accordance with one embodiment of thepresent specification;

FIG. 3I is an illustration depicting a wire mesh structure having firstand second pluralities of nodes at its proximal and distal endsrespectively, and third and fourth pluralities of nodes distributedalong its surface, in accordance with one embodiment of the presentspecification;

FIG. 3J to FIG. 3N are illustrations depicting various possible nodeshapes in accordance with multiple embodiments of the presentspecification;

FIG. 4A is a close-up illustration of an atraumatic anti-migrationcollar of a wire mesh structure of an intragastric device, in accordancewith one embodiment of the present specification;

FIG. 4B is a close-up illustration of an atraumatic anti-migrationcollar of a wire mesh structure of an intragastric device, in accordancewith another embodiment of the present specification;

FIG. 4C is an illustration of hoops formed from twisting free ends oflong nodes in accordance with at least one embodiment;

FIG. 4D is an illustration of hoops that are sutured to the free ends oflong nodes in accordance with at least one embodiment;

FIG. 4E is a close-up illustration of an atraumatic anti-migrationcollar of a wire mesh structure of an intragastric device, in accordancewith yet another embodiment of the present specification;

FIG. 4F is an illustration of hoops formed from twisting free ends oflong nodes in accordance with at least one embodiment;

FIG. 4G is an illustration of hoops that are sutured to the free ends oflong nodes in accordance with at least one embodiment;

FIG. 5A is an illustration of a portion of a sleeve component of anintragastric device in a post-deployment configuration depicting asingle wire support spiraling along the body of the sleeve in accordancewith at least one embodiment;

FIG. 5B is an illustration of a portion of a sleeve component of anintragastric device in a post-deployment configuration depictingmultiple wire supports spiraling along the body of the sleeve inaccordance with at least one embodiment;

FIG. 5C is an illustration of a funnel shaped sleeve component of anintragastric device in a post-deployment configuration depicting spiralwire loop supports on the sleeve in accordance with at least oneembodiment;

FIG. 5D is an illustration of a set of wire loop supports for the funnelshaped sleeve of FIG. 5C in accordance with at least one embodiment;

FIG. 5E is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration depicting a funnel shapedopening at the proximal end of the sleeve in accordance with at leastone embodiment;

FIG. 5F is an illustration of a funnel shaped sleeve component of anintragastric device in a post-deployment configuration depicting aplurality of markings on an outer surface of the sleeve body inaccordance with at least one embodiment;

FIG. 5G is an illustration of a funnel shaped sleeve component of anintragastric device in a post-deployment configuration depicting amarking line extending along the length of the sleeve on an outersurface of the sleeve body in accordance with at least one embodiment;

FIG. 5H is an illustration of a funnel shaped sleeve component of anintragastric device in a post-deployment configuration depicting aplurality of markings and a marking line extending along the length ofthe sleeve on an outer surface of the sleeve body in accordance with atleast one embodiment;

FIG. 6A is a cross-sectional illustration of a funnel shaped sleevecomponent of an intragastric device in a post-deployment configurationdepicting a plurality of sleeve layers in accordance with at least oneembodiment;

FIG. 6B is a cross-sectional illustration of a funnel shaped sleevecomponent of an intragastric device in a post-deployment configurationdepicting a plurality of sleeve layers in accordance with at least oneembodiment;

FIG. 6C is a cross-sectional illustration of a funnel shaped sleevecomponent of an intragastric device in a post-deployment configurationdepicting a plurality of sleeve layers in accordance with at least oneembodiment;

FIGS. 6D and 6E are cross-sectional illustration of funnel shaped sleevecomponents of an intragastric device in a post-deployment configurationdepicting a plurality of sleeve layers in accordance with at least oneembodiment;

FIG. 6F is a cross-sectional illustration of a sleeve component of FIG.6E in accordance with at least one embodiment;

FIG. 6G is a cross-sectional illustration of a funnel shaped sleevecomponent of an intragastric device in a post-deployment configurationin accordance with yet another embodiment of the present specification;

FIG. 6H is an illustration of a stent support for a sleeve component ofan intragastric device, in accordance with one embodiment of the presentspecification;

FIG. 6I is an illustration of a sleeve component of an intragastricdevice having the stent support of FIG. 6F in accordance with at leastone embodiment;

FIG. 6J illustrates a portion of a sleeve of a wire mesh device coveredwith a nano-fiber membrane, in accordance with an embodiment of thepresent specification;

FIG. 7 is an illustration of a funnel shape sleeve for an intragastricdevice, in accordance with one embodiment of the present specification;

FIG. 8 is an illustration of a funnel shape sleeve for an intragastricdevice, in accordance with another embodiment of the presentspecification;

FIG. 9A is an illustration of a wire mesh structure with attached sleevecomponent in a post-deployment configuration depicting a blunt end of awire mesh support toward the proximal end of the sleeve in accordancewith at least one embodiment;

FIG. 9B is an illustration of a wire mesh structure with a proximalportion of an attached sleeve component in a post deploymentconfiguration depicting a delivery catheter positioned within the wiremesh structure in accordance with at least one embodiment;

FIG. 10A is an illustration of a funnel shaped braided short sleevecomponent in a post-deployment configuration, in accordance with oneembodiment of the present specification;

FIG. 10B is an illustration of a funnel shaped braided short sleevecomponent having a cone shaped distal end in a post-deploymentconfiguration, in accordance with one embodiment of the presentspecification;

FIG. 10C is an illustration of a cone shape braided short sleevecomponent in a post-deployment configuration, in accordance with oneembodiment of the present specification;

FIG. 10D is an illustration of the cone shape braided short sleevecomponent of FIG. 10C attached to a wire mesh structure in accordancewith one embodiment of the present specification;

FIG. 10E is an illustration of a cone shape braided short sleevecomponent in a post-deployment configuration, in accordance with anotherembodiment of the present specification;

FIG. 10F is an illustration of the cone shape braided short sleevecomponent of FIG. 10E attached to a wire mesh structure in accordancewith one embodiment of the present specification;

FIG. 10G is an illustration of a cone shape braided short sleevecomponent having an atraumatic distal tip and in a post-deploymentconfiguration, in accordance with one embodiment of the presentspecification;

FIG. 10H is an illustration of a cone shape braided short sleevecomponent having an atraumatic distal tip and in a post-deploymentconfiguration, in accordance with another embodiment of the presentspecification;

FIG. 11A is a cross-sectional illustration depicting one embodiment ofan intragastric device with an attached sleeve in a post-deploymentconfiguration in accordance with at least one embodiment;

FIG. 11B is a cross-sectional illustration depicting the intragastricdevice of FIG. 11A in a pre-deployment configuration in accordance withat least one embodiment;

FIG. 11C is a cross-sectional illustration depicting an intragastricdevice with an attached sleeve in a post-deployment configuration inaccordance with at least one embodiment;

FIG. 11D is a cross-sectional illustration depicting the intragastricdevice of FIG. 11C in a pre-deployment configuration in accordance withat least one embodiment;

FIG. 12A is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with one embodiment of the presentspecification;

FIG. 12B is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with another embodiment of thepresent specification;

FIG. 12C is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with another embodiment of thepresent specification;

FIG. 12D is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with another embodiment of thepresent specification;

FIG. 12E is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with another embodiment of thepresent specification;

FIG. 12F is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with yet another embodiment of thepresent specification;

FIG. 13A is an illustration of a plurality of nodes positioned at thedistal end of a wire mesh structure connected to the proximal end of afunnel shaped sleeve, in accordance with an embodiment of the presentspecification;

FIG. 13B is an illustration of a distal end of a wire structure andconnected proximal end of a funnel shaped sleeve covered with a heatshrink tube, in accordance with one embodiment of the presentspecification;

FIG. 14 is an illustration of an intragastric device with a funnelshaped sleeve in a post-deployment configuration, in accordance with oneembodiment of the present specification;

FIG. 15 is an illustration of an intragastric device with acylindrically shaped sleeve in a post-deployment configuration, inaccordance with one embodiment of the present specification;

FIG. 16A is a close-up illustration of a funnel shaped sleeve attachedto an anti-migration collar of a wire mesh structure of an intragastricdevice, in accordance with one embodiment of the present specification;

FIG. 16B is a close-up illustration of a funnel shaped sleeve attachedto an anti-migration collar of a wire mesh structure of an intragastricdevice and having a proximal sleeve end having frayed edges, inaccordance with another embodiment of the present specification;

FIG. 16C is an illustration of an intragastric device comprising a wiremesh structure and attached sleeve, in accordance with one embodiment ofthe present specification;

FIG. 16D is an illustration of the intragastric device of FIG. 16C withthe sleeve straightened to depict the device dimensions relative to thesurrounding anatomy;

FIG. 16E is an illustration of a wire mesh structure and sleeve of anintragastric device, depicting retrieval drawstrings on said wire meshstructure, in accordance with one embodiment of the presentspecification;

FIG. 16F is an illustration of a wire mesh structure and sleeve of anintragastric device, depicting a single retrieval drawstring on saidwire mesh structure, in accordance with one embodiment of the presentspecification;

FIG. 17A is a cross-sectional illustration of a distal end of a sleeve,depicting one embodiment of a component designed to configure saiddistal end to be atraumatic to body tissues;

FIG. 17B is a cross-sectional illustration of a distal end of a sleeve,depicting another embodiment of a component designed to configure saiddistal end to be atraumatic to body tissues;

FIG. 17C is a cross-sectional illustration of a distal end of a sleeve,depicting another embodiment of a component designed to configure saiddistal end to be atraumatic to body tissues;

FIG. 18 is an illustration of a distal end of a sleeve with apositioning tail attached thereto, in accordance with one embodiment ofthe present specification;

FIG. 19A is an illustration of a distal end of a sleeve comprising aplurality of fringes joined to a ring, in accordance with one embodimentof the present specification;

FIG. 19B is an illustration of a distal end of a sleeve comprising aplurality of fringes joined to a ball, in accordance with one embodimentof the present specification;

FIG. 19C is a cross sectional illustration of a ball attached to adistal end of a sleeve, in accordance with one embodiment of the presentspecification;

FIG. 19D is an illustration of a distal end of a sleeve having aplurality of sutures extending therefrom and joined to a ball, inaccordance with one embodiment of the present specification;

FIG. 19E is an illustration of a distal end of a sleeve having at leastone suture with attached suture loop or bead extending therefrom, inaccordance with one embodiment of the present specification;

FIG. 20A is an illustration of a distal end of a sleeve depicting atleast one fold in the sleeve wall, in accordance with one embodiment ofthe present specification;

FIG. 20B is an illustration of a distal end of a sleeve depicting atleast one channel and support structure within the sleeve wall, inaccordance with one embodiment of the present specification;

FIG. 20C is an illustration of a portion of a sleeve depicting acorrugated sleeve wall in accordance with one embodiment of the presentspecification;

FIG. 20D is an illustration of portion of a sleeve depicting a knittedsleeve wall in accordance with one embodiment of the presentspecification;

FIG. 20E is an illustration of portion of a sleeve depicting a knittedsleeve wall and a distal sleeve end having frayed edges, in accordancewith one embodiment of the present specification;

FIGS. 20F to 20L are illustrations of exemplary sleeve knit patterns inaccordance with various embodiments of the present specification;

FIG. 21A is an illustration of an intragastric device having an ovalshaped wire mesh structure deployed in the gastrointestinal tract of apatient, in accordance with one embodiment of the present specification;

FIG. 21B is an illustration of an intragastric device having an ovalshaped wire mesh structure deployed in the gastrointestinal tract of apatient, in accordance with another embodiment of the presentspecification;

FIG. 21C is an illustration of several views of a pylorus of a patientin an open state and a closed state with and without a sleeve of anintragastric device passing therethrough, in accordance with someembodiments of the present specification;

FIG. 21D is an illustration of a pylorus of a patient in an open andclosed state with a sleeve of an intragastric device passingtherethrough in accordance with at least one embodiment;

FIG. 22A is an illustration of an expanded wire mesh structure of afirst intragastric device in accordance with at least one embodiment;

FIG. 22B is a constricted wire mesh structure of a second intragastricdevice coupled to the distal end of an implantation catheter, inaccordance with one embodiment of the present specification;

FIG. 23 is an illustration of an intragastric device with a partiallyconstrained wire mesh structure on a delivery catheter, in accordancewith one embodiment of the present specification;

FIG. 24A is an illustration of an exemplary delivery device for anintragastric device, in accordance with one embodiment of the presentspecification;

FIG. 24B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 24A, inaccordance with one embodiment of the present specification;

FIG. 25A is an illustration of an exemplary delivery device for anintragastric device, in accordance with one embodiment of the presentspecification;

FIG. 25B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 25A, inaccordance with one embodiment of the present specification;

FIG. 25C is a flow chart illustrating the steps involved in deliveringan intragastric device using a delivery device comprising a pull awaysheath, in accordance with one embodiment of the present specification;

FIG. 26A is an illustration of another exemplary delivery device for anintragastric device, in accordance with one embodiment of the presentspecification;

FIG. 26B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 26A, inaccordance with one embodiment of the present specification;

FIG. 26C is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 26A, inaccordance with another embodiment of the present specification;

FIG. 26D is a flow chart illustrating the steps involved in delivering awire mesh structure and sleeve separately and assembling an intragastricdevice within a patient's gastrointestinal tract in accordance with atleast one embodiment;

FIG. 27A is an illustration of yet another exemplary delivery device foran intragastric device, in accordance with one embodiment of the presentspecification;

FIG. 27B is another illustration of the delivery device of FIG. 27A,depicting the relative lengths of various components of the deliverydevice in accordance with at least one embodiment;

FIG. 27C is an illustration of a distal end of a delivery devicedepicting a pilot olive for navigation, in accordance with oneembodiment of the present specification;

FIG. 27D is an illustration of a portion of a delivery device depictinga mesh retention component, in accordance with one embodiment of thepresent specification;

FIG. 27E is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 27A, inaccordance with one embodiment of the present specification;

FIG. 28A is an illustration of another exemplary delivery device for anintragastric device, in accordance with one embodiment of the presentspecification;

FIG. 28B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 28A, inaccordance with one embodiment of the present specification;

FIG. 29A is an illustration of another exemplary delivery device for anintragastric device, in accordance with one embodiment of the presentspecification;

FIG. 29B is a cross sectional illustration of a pre-deployment coaxialarrangement of a sleeve of an intragastric device within a deliverydevice, in accordance with one embodiment of the present specification;

FIG. 29C is a cross sectional illustration of a pre-deployment coaxialarrangement of a sleeve of an intragastric device within a deliverydevice, in accordance with another embodiment of the presentspecification;

FIG. 29D is a cross sectional illustration of a pre-deployment coaxialarrangement of a sleeve of an intragastric device within a deliverydevice depicted over an endoscope, in accordance with one embodiment ofthe present specification;

FIG. 29E is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 29A, inaccordance with one embodiment of the present specification;

FIG. 30A is an illustration of a seventh exemplary delivery device foran intragastric device, in accordance with one embodiment of the presentspecification;

FIG. 30B is an illustration of one exemplary embodiment of an outercatheter for use in the delivery device of FIG. 30A in accordance withat least one embodiment;

FIG. 30C is an illustration of another embodiment of an outer catheterdepicting the dimensions a compressed sleeve and compressed wire meshstructure of an intragastric device relative to the dimensions of theouter catheter in accordance with at least one embodiment;

FIG. 30D is a close up illustration of the distal end of the deliverydevice of FIG. 30A, depicting the pilot component and proximal anddistal spherical components in accordance with at least one embodiment;

FIG. 30E is an illustration of the proximal end of the delivery deviceof FIG. 30A, depicting the outer catheter retracted to a first stoppingmechanism in accordance with at least one embodiment;

FIG. 30F is an illustration of one embodiment of a sleeve of anintragastric device partially deployed corresponding to the outercatheter position depicted in FIG. 30E in accordance with at least oneembodiment;

FIG. 30G is an illustration of the proximal end of the delivery deviceof FIG. 30A, depicting the outer catheter retracted to a second stoppingmechanism in accordance with at least one embodiment;

FIG. 30H is an illustration of one embodiment of a wire mesh structureof an intragastric device partially deployed corresponding to the outercatheter position depicted in FIG. 30I in accordance with at least oneembodiment;

FIG. 30I is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 30A, inaccordance with one embodiment of the present specification;

FIG. 31A is an illustration of a wire mesh structure of an intragastricdevice being loaded onto a delivery device, in accordance with oneembodiment of the present specification;

FIG. 31B is an illustration of the wire mesh structure of FIG. 31Afurther loaded onto the delivery device in accordance with at least oneembodiment;

FIG. 31C is an illustration of the wire mesh structure of FIG. 31Aloaded onto the delivery device such that only the anti-migration collarremains to be loaded in accordance with at least one embodiment;

FIG. 31D is an illustration of the wire mesh structure of FIG. 31A fullyloaded onto the delivery device in accordance with at least oneembodiment;

FIG. 31E is an illustration of a sleeve of the intragastric device ofFIG. 31A partially loaded onto the delivery device in accordance with atleast one embodiment;

FIG. 31F is an illustration of the intragastric device of FIG. 31A fullyloaded onto the delivery device in accordance with at least oneembodiment;

FIG. 32A is an illustration of a retrieval device for removing anintragastric device, in accordance with one embodiment of the presentspecification;

FIG. 32B is a flow chart illustrating the steps involved in removing anintragastric device from a patient using the retrieval device of FIG.31A, in accordance with one embodiment of the present specification;

FIG. 33A is an illustration of an embodiment of an intragastric devicein an exemplary post-deployment configuration having a dumbbell shape inaccordance with at least one embodiment;

FIG. 33B is an illustration of an embodiment of an intragastric devicehaving a double-wire mesh structure wherein the lower wire mesh isformed from an everted anti-migration component in accordance with atleast one embodiment;

FIG. 34A is an illustration of an exemplary intragastric device having adouble-wire mesh structure in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 34B is an illustration of another exemplary intragastric devicehaving a double-wire mesh structure in a post-deployment configurationin accordance with one embodiment of the present specification;

FIG. 34C is an illustration of another exemplary intragastric devicehaving a double-wire mesh structure in a post-deployment configurationin accordance with one embodiment of the present specification;

FIG. 34D is an illustration of another exemplary intragastric devicehaving a double-wire mesh structure in a post-deployment configurationin accordance with one embodiment of the present specification;

FIG. 34E is an illustration of another exemplary intragastric devicehaving a double-wire mesh structure in a post-deployment configurationin accordance with one embodiment of the present specification;

FIG. 34F is an illustration of another exemplary intragastric devicehaving a double-wire mesh structure in a post-deployment configurationin accordance with one embodiment of the present specification;

FIGS. 34G and 34H are illustrations of another exemplary double-wiremesh intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 34I is an illustration of an intragastric device having two wiremeshes coupled with an anti-migration feature, in accordance with anembodiment of the present specification;

FIG. 34J is an illustration of a top view of the intragastric device ofFIG. 341 showing the diameter of the opening in accordance with at leastone embodiment;

FIG. 34K is an illustration of a portion of an anti-migration componentattached to a portion of the first and second wire mesh structure bywires in accordance with at least one embodiment;

FIGS. 34L and 34M are illustrations of loops formed in the wire meshstructures in accordance with at least one embodiment;

FIG. 35 is an illustration of one single exemplary intragastric devicebeing attached to a previously deployed single intragastric device in astomach in accordance with at least one embodiment;

FIG. 36 is an illustration of an exemplary fully deployed combinedintragastric device in a stomach in accordance with at least oneembodiment;

FIG. 37A is a side perspective view of an exemplary intragastric devicehaving a combined dual-wire mesh structure in a post-deploymentconfiguration in accordance with one embodiment of the presentspecification;

FIG. 37B is an oblique perspective view of the intragastric device ofFIG. 37A in accordance with at least one embodiment;

FIG. 37C is an illustration of a plurality of sutures to flexiblyconnect first and second wire mesh structures of the intragastric deviceof FIG. 37A in accordance with at least one embodiment;

FIG. 37D is an illustration of a sleeve coupled to the intragastricdevice of FIG. 37A, in accordance with an embodiment of the presentspecification;

FIG. 37E is an illustration of two exemplary suture points that flexiblyconnect first and second wire mesh structures of the intragastric deviceof FIG. 37A in accordance with at least one embodiment;

FIG. 37F is an illustration of a relative degree of movement of firstand second wire mesh structures of the intragastric device of FIG. 37Ain accordance with at least one embodiment;

FIG. 38A is an illustration of a process of deploying a combinedintragastric device wherein one wire mesh structure is nearly completelydeployed while the other wire mesh structure is still constrained in acatheter in accordance with at least one embodiment;

FIG. 38B is an illustration of a process of withdrawing or removing thecombined intragastric device wherein one wire mesh structure ispartially constrained within the catheter while the other wire meshstructure is still in unconstrained or deployed state in accordance withat least one embodiment;

FIG. 38C is an illustration of the process of withdrawing or removingthe combined intragastric device wherein one wire mesh structure whenfully constrained within the catheter causes the other wire meshstructure to be aligned or oriented for compression within the catheterin accordance with at least one embodiment; and

FIG. 38D illustrates that the aligned or oriented wire mesh structurebegins to get constrained or compressed into the catheter for removal,as the fully compressed wire mesh structure is further withdrawn intothe catheter in accordance with at least one embodiment.

DETAILED DESCRIPTION

In one embodiment, the present specification is directed toward anintragastric device of dynamic weight used in obese patients to induceweight loss. In various embodiments, the intragastric device comprises aporous three dimensional structure having a pre-deployment shape and apost-deployment shape. In one embodiment, the porous three dimensionalstructure is a non-inflatable wire mesh structure, or a spiral structuremade of shape memory metal or shape memory polymer that changes from apre-deployment compressed cylindrical shape to a post-deployment sphere,oval, kidney bean or any predefined shape of significant volume. Inanother embodiment, the intragastric device is made of a plasticmaterial or a polymer such as polyether ether ketone (PEEK) or polyesteror a bioresorbable material. The device changes back and forth from thepre-deployment to post-deployment shape by minimal mechanical forceand/or temperature changes arising from the room temperaturepre-deployment shape to the body temperature post-deployment shape. Thedevice is delivered endoscopically to the stomach via a catheter. Thedevice can be placed through the endoscope, over an endoscope or over aguidewire with endoscopic or fluoroscopic guidance/assistance.

The device has a pre-deployment compressed shape to facilitate insertionand a post-deployment expanded shape that resides in the gastric lumen.Post-deployment volume of the device is significantly larger thanpre-deployment volume. In one embodiment, the post-deployment device hasa volume of at least 100 ml. The post-deployment device occupies asignificant volume in the stomach, thereby reducing available gastricvolume available for storage of ingested food. This restricts the amountof food intake, inducing satiety and curbing one's appetite. In oneembodiment, the device is also designed to intermittently, with gastricperistalsis, slow or block the passage of the food from the stomach intothe small intestine, thereby slowing gastric emptying. In variousembodiments, the device also functions to create a biliopancreaticdiversion, either by bypassing ingested food past pancreatic secretionsor by bypassing pancreatic secretions past ingested food.

In one embodiment, the device comprises a shape memory metal andself-expands once deployed to change from the pre-deployment shape tothe post-deployment shape. In another embodiment, the device comprises atemperature sensitive metal that is cooled in its pre-deployment shapeand then self-expands when exposed to human body temperature to achieveits post-deployment shape. In another embodiment, an expansion tool isused to apply minimal mechanical force to change the device shape fromits pre-deployment shape to its post-deployment shape. In anotherembodiment, a plastic, polymer, carbon fiber or a bioresorbable materialis used to construct the intragastric device.

In one embodiment, the wire structure contains differently weightedmaterial to assist in proper positioning within the stomach. In oneembodiment, lighter weighted material is positioned at the top of thewire structure proximate to the top openings and heavier weightedmaterial is positioned at the bottom of the structure, proximate to thebottom openings. This differential weighting insures that the devicewill be properly situated within the stomach to effectuate the intendedeffect of slower gastric emptying. In addition, the differentialweighting provides for proper gastric positioning without the need ofphysically anchoring the wire mesh structure to the stomach wall. Thedifferential weight property can also be provided by the ingested foodmaterial that enters the device and is selectively accumulated towardthe bottom of the device facilitated by the gravitational pull. Thedifferential weight can also be provided by using different amounts ofmaterial in the top and bottom halves. The wire mesh structure is freeto move about within the stomach while still maintaining its correct topto bottom alignment facilitated by the gravitational pull.

In one embodiment, the device comprises a wire mesh structure which,when in the post-deployment shape, includes mesh openings between thewires of the mesh structure. In one embodiment, the mesh openings aregreater than 1 mm in diameter. In one embodiment, the wires of the wiremesh structure are coated with a corrosion-resistant material. Thecorrosion resistant material prevents exposure and subsequentdegradation of the wires of the wire mesh structure from acidic gastriccontents once deployed. The corrosion-resistant material completelycovers the wires of the wire mesh but does not cover the mesh openings.In one embodiment, the corrosion-resistant material comprises parylene.Parylene is beneficial as a coating in that it is durable, may mitigatenickel ion leaching, and has a lower profile (is thinner once applied).In various embodiments, the corrosion-resistant material comprisessilicone, polyester, polyether ether ketone (PEEK), a medical gradeepoxy, ceramic, an additional metal, or any other suitable, flexiblecorrosive resistant material. In one embodiment, the coating metal istantalum. Tantalum provides corrosive resistance and radio-opacity. Inone embodiment, wherein the coating is ceramic, the ceramic coating hasa thickness of several angstroms. In various embodiments, any one orcombination of the above corrosive resistant materials is used to coatthe metal of the wire mesh structure.

In one embodiment, the mesh openings are differentially structured toregulate the flow of food in and out of the mesh. In one embodiment, atleast one opening on the bottom half of the device is larger than any ofthe openings on the upper half of the device, allowing food entering themesh to exit without the need for further reduction in size of foodmaterial.

In another embodiment, the intragastric device further includes ananti-migration component, or collar, coupled to a portion of its distalend. The anti-migration component, similar to the wire mesh of theintragastric device, is configurable between a first, compressedconfiguration for delivery, and a second, expanded configuration oncedeployed. The anti-migration component functions as a physical stopperpreventing passage of the intragastric device through the pylorus. Invarious embodiments, the anti-migration component has a diameter that isgreater than the diameter of a relaxed pylorus. In one embodiment, theanti-migration component comprises an extension of the wire meshstructure of the intragastric device. In another embodiment, theanti-migration component is a separate piece of wire mesh which isattached to a portion of the distal end of the intragastric device. Invarious embodiments, the anti-migration component has a shapeapproximating a bumper, half-bumper, disc, saucer, or any other shapewhich will prevent migration of the device past the pylorus. In general,the anti-migration collar has a dimension, such as a diameter or length,which 1) is greater than a diameter of the distal opening of the wiremesh structure and 2) is attached to, or integrally formed with, thewire mesh structure distal to the distal opening. In one embodiment,such a diameter or length is in a range of 10 mm to 300 mm.

In other embodiments, a sleeve can be attached to the intragastricdevice, where the sleeve extends from the stomach into the duodenumwhere it empties, or through the duodenum and into the jejunum. In oneembodiment, the sleeve functions to transit the sequestered chyme fromthe wire mesh structure directly to the mid duodenum or mid-jejunum. Inanother embodiment, the sleeve is coupled to the intragastric device butdoes not directly receive food from the device. In this embodiment, theproximal end of the sleeve is distal to the device and receives fooddirectly from either the stomach or the duodenum. The food entering thesleeve exits at the distal end, into the duodenum or jejunum, bypassinga portion of the small intestine.

The sleeve therefore acts to bypass portions of the gastrointestinal(GI) tract in order to limit the absorption of specific materials in theintestine. The benefits provided by a sleeve are similar to thoseprovided by Roux-en-Y gastric bypass surgery, namely, weight loss andimprovement of type II diabetes.

After implantation, the gastrointestinal device of the presentspecification, particularly the collar, is in constant physical contactwith the patient's anatomy without being actually physically attached tothe patient's anatomy. This is accomplished by the sleeve being pulleddown by the peristaltic actions of the small intestine. As the sleeve ispulled down, the collar of the wire mesh structure contacts the stomachproximal to the pylorus. The sleeve is constantly in physical contactwith the pylorus. However, this constant contact with the pylorus doesnot block food passage. The openings of the wire mesh structure and thelumen of the sleeve pass food through pylorus without occluding it atany point, allowing the food to pass into the intestines. Theintragastric device of the present specification physically engages thegastric emptying region of stomach without fully occluding it any point.The intragastric device of the present specification functions as avariable outlet drain and does not act as a stopper to the passage offood.

The gastrointestinal device of the present specification is designed tomaximize the amount of food captured and passed through the sleeve andinto the intestines rather than minimizing the amount of food passinginto intestines. By being in constant contact with the pylorus andstomach, the device is designed to prevent food from passing around andoutside of it. In various embodiments, at least 10% of the food exitinga patient's stomach passes through the device and not around the device.In one embodiment, at least 50% of the food exiting a patient's stomachpasses through the device and not around the device. In variousembodiments, this food that passes into the device and through thesleeve never comes into contact with the patient's duodenum, therebyallowing the device to function as a true pyloric bypass.

In one embodiment, the device is an inflatable balloon with an attachedsleeve, wherein the balloon is not in fluid communication with a lumenof the sleeve and the balloon merely acts to hold the sleeve in positionwithout the need to anchor or fix the sleeve to the gastrointestinalwall. The balloon can be inflated or deflated with fluid and is designedto reside in a person's stomach. The sleeve is flexibly attached to theballoon and has a proximal opening and a distal opening wherein theproximal opening is designed to reside proximal to a patient's ampullaand the distal opening is designed to reside distal to a patient'sampulla. Partially digested food enters the proximal opening and exitsthe distal opening, bypassing the ampullary region. The sleeve is notanchored or fixed to any portion of the gastrointestinal wall.

Wire Mesh Structure

In various embodiments, the intragastric device comprises a porous threedimensional structure having a pre-deployment shape and apost-deployment shape. In one embodiment, the device, in thepost-deployment configuration, comprises a three dimensional wire meshstructure defining an internal volume and having a proximal end and adistal end.

In various embodiments, the wire mesh structure includes free ends or‘nodes’ comprising bends or curves in the wire of the wire meshstructure wherein these bends or curves are unsupported and notconnected to any other portion of the wire mesh. In some embodiments,the wire mesh structure includes two pluralities of nodes. A firstplurality is positioned at the proximal end of the structure and asecond plurality is positioned at the distal end of the structure. Whenthe wire mesh structure is compressed to its pre-deploymentconfiguration, the first and second plurality of nodes at the proximaland distal ends of the structure respectively, become gathered togetheror ‘bunched up’. This creates a larger cross-sectional area (ordiameter) at the proximal and distal ends of the structure when comparedto the cross-sectional area of the compressed structure between saidends. As its cross-sectional area becomes larger, the compressed wiremesh structure becomes increasingly difficult to deploy through a narrowdelivery device or catheter. This delivery problem can be addressed inat least two different ways. In various embodiments, the number of nodesin each plurality of nodes is reduced. Reducing the number of nodes ineach plurality makes the structure easier to compress and creates asmaller cross-sectional area at the ends of the structure. This reducesthe force applied by the compressed structure to the delivery catheter,thereby making it easier to pass the compressed structure through thecatheter. In various embodiments, a portion of the nodes from one orboth of the first and second plurality of nodes is moved from said endsof the structure and positioned along the body of the structure,creating additional pluralities of nodes. This ‘staggering’ of the nodesreduces the cross-sectional area of the compressed structure at anygiven point and distributes the force applied by the compressedstructure to the delivery catheter, again easing the passage of thedelivery structure through the catheter. In various embodiments, thenumber of nodes in each plurality is reduced and the nodes are staggeredin multiple pluralities throughout the structure to reduce anddistribute the force applied by the compressed structure to the deliverycatheter. Reducing and distributing said force allows for easierdelivery and for the use of a delivery catheter having a smallerdiameter. Reduced and distributed forces also allow for the creation oflarger mesh structures that can be compressed to smaller sizes.

In various embodiments, each plurality of nodes comprises 10 to 100individual nodes. In one embodiment, each plurality of nodes comprises44 nodes. In another embodiment, each plurality of nodes comprises 36nodes. In various embodiments, a wire mesh structure includes 2 to 60pluralities of nodes distributed latitudinally at different locationsalong its length. In one embodiment, the nodes are staggered such thatat least 10% of the total number of nodes in the structure arepositioned at the proximal and distal ends. In various embodiments, nomore than 75% of the total number of nodes are positioned in any oneplurality of nodes. In various embodiments, the nodes are distributedwithin at least three different lateral pluralities along the length ofthe structure.

The compressibility of the wire mesh structure also depends on theflexibility of the mesh. The flexibility, in turn, depends upon, amongother variables, the thickness of the wire, the angle of wireintersections, and the number of wires. Regarding the angle of wireintersections, as the wires of the structure are arranged more parallelto one another, the structure becomes more flexible. In variousembodiments, the wire mesh structure, in a pre-deployment configuration,has an overall length of 5 to 50 cm and each wire has a thickness in arange of 0.1 to 1 mm. In one embodiment, each wire has a thickness of0.44 mm. The wires of the wire mesh structure have a bending strainwhich determines how they behave as the structure is compressed. Invarious embodiments, the wires are comprised of a shape memory metal,such as, in one embodiment, Nitinol. The shape memory metal has acertain bending strain percentage beyond which the metal loses itsability to exactly regain its previous shape. The strain percentage (%)can be defined by the following formula:

strain %=2t/R×100

wherein t=thickness of the wire and R=radius of the bend. In oneembodiment, once the strain percentage reaches 8%, a permanent change isintroduced to the shape memory metal such that it will no longer returnfully to its original shape. This factor becomes important as the wiremesh structure is compressed to its pre-deployment shape for delivery.In various embodiments, the wire mesh structure includes a collar orcircular extension of the wire mesh at its distal end which functions asan anti-migration component. This collar must me folded out distallyduring compression such that the compressed structure will fit into thedelivery device or catheter. A ‘bump’ in the wire mesh structure isintroduced as the collar is folded out during compression. A strainpercentage of less than 8% creates a smaller bump in the compressed wiremesh structure, allowing for easier passage of the compressed structurethrough a delivery catheter. Therefore, in various embodiments, the wiremesh structure is configured having a wire thickness and a bend radiusat the collar such that the strain percentage at the collar will be nomore than 20%, and preferably less than 8%. In various embodiments, theradius of the collar is less than 10 times the wire thickness. Invarious embodiments, the strain percentage is in a range of 0.1 to 20%.In various embodiments, the wire of the wire mesh has a thickness of 0.1to 1.0 mm and the collar has a bend radius of 0.013 to 20 cm. In oneembodiment, the wire of the wire mesh has a thickness of 0.4 mm. Invarious embodiments, the wire thickness and bend radius are configuredto satisfy the following statement:

2t<R<2000t

wherein t=thickness of the wire and R=radius of the bend.

In various embodiments, the ends of the wire(s) of the wire meshstructure are terminated in such a way to minimize the possibility oftraumatic injury to body tissues during delivery and retrieval and whiledeployed. In some embodiments, the wire mesh structure comprises asingle wire folded into a three dimensional structure. In otherembodiments, the wire mesh structure comprises more than one wire joinedand folded into a three dimensional structure. In various embodiments,the free ends of the wire or wires are joined by crimping a titaniumtube or Nitinol (or other shape memory metal) tube over said free ends.In other embodiments, the free ends of the wire or wires are joined byspot welding said free ends together. In one embodiment, theintersections of the wires are not welded. In another embodiment, theintersections of the wires are welded.

Sleeve

In various embodiments, the intragastric device of the presentspecification further comprises a flexible sleeve component coupled tothe wire mesh structure. In multiple embodiments, any of the wire meshstructures discussed above is coupled with any of the sleeve componentsdiscussed below. The sleeve component comprises an elongate tubular bodyhaving a proximal end and a distal end a lumen within.

In one embodiment, the sleeve has a consistent diameter along its entirelength. In other embodiments, the sleeve comprises a funnel shapeproximate its proximal end wherein the diameter of the sleeve isgreatest at the first opening at the proximal end of the sleeve body andthen decreases gradually as it extends distally until it reaches aminimum diameter at a position proximal to the midpoint of its length.The diameter then remains constant distally along the remainder of itslength.

In various embodiments, wherein the wire mesh structure includes acollar at its distal end, the proximal end of the sleeve is attached tothe bottom surface of said collar by one of the means listed above. Invarious embodiments, when the device is compressed into itspre-deployment configuration, the sleeve body is pulled upon to assistin folding out the collar. If the proximal end of the sleeve is attachedto the bottom surface of the collar as described above, the collar isnot fully straightened when folded out, resulting in the creation of alarge bulge at the collar when the device is in the pre-deploymentconfiguration. The bulge has a large diameter comprising the thicknessof the wire mesh structure and double the thickness of the sleeve.Therefore, in preferred embodiments, the proximal end of the sleeve isattached to the free ends, or nodes, of the collar by a plurality ofloose sutures. The sleeve is sutured to each node much similar to theway in which the fabric of an umbrella is attached to the end of eachspine of the umbrella. When an umbrella is closed, the fabric collapsesdown to allow for compression. The intragastric device of the presentspecification functions in a similar manner. In various embodiments, asthe wire mesh structure is compressed for loading onto a deliverydevice, the distal end of the sleeve is pulled upon. The loose suturesattaching the sleeve to the nodes of the wire mesh allow the sleeve tomove relative to the wire mesh such that the collar is pulled distallyand extended into a more linear shape. Such an attachment avoids thecreation of a large bulge at the collar of the pre-deploymentconfiguration. When the sleeve body is pulled upon during compression,the collar is folded out more completely and the resultant bulge has asmaller diameter, comprising only the thickness of the wire meshstructure. In various embodiments, when the intragastric device is inthe pre-deployment configuration, there is minimum to zero overlapbetween the collar and the sleeve. Upon deployment, the shape memoryproperties of the wire mesh structure cause the collar to pull thesleeve onto itself as it expands, much like an umbrella expanding itsfabric as it opens.

In various embodiments, each node at the distal end of the wire meshstructure (or collar) is attached to the proximal end of the sleeve viaa suture. This can lead to bulking at the attachment of the wire meshstructure to the sleeve. Therefore, in other embodiments, fewer nodesare sutured to the sleeve. For example, in one embodiment, every othernode is sutured to the sleeve to reduce the number of suture knots anddecrease bulking. The inclusion of glue and multiple loops in eachsuture knot can also lead to bulking at the attachment point of the wiremesh structure to the sleeve. As such, in various embodiments, glue isnot used and each suture knot is limited to one loop. Suturing of thesleeve to the nodes can lead to sliding of the suture knots along thelength of wire comprising the nodes, resulting in unintended movement ofthe sleeve relative to the wire mesh structure. To prevent sliding, invarious embodiments, each suture knot is placed at the first junctionsof the wires proximal to each node. In effect, each suture is thenplaced over two wires and cannot slide along one or the other. Toeliminate excessive bulking, in various embodiments, fewer than everyfirst wire junction is sutured to the sleeve. For example, in oneembodiment, every other first wire junction is sutured to the sleeve.

In various embodiments, any sharp ends of wires in the wire mesh and/orsleeve are crimped and looped onto themselves or looped outward to actas pulling points for moving the sleeve into the intestines or forconnecting the sleeve to the wire mesh structure.

The distal end of the sleeve can be designed to be weighted so that thesleeve remains in an elongated shape extending through a portion of theduodenum. In one embodiment, the sleeve includes a small weight attachedto its distal end. In another embodiment, wherein the second opening atthe distal end of the sleeve body is positioned along the sleeve body atits distal end, the distal end of the sleeve body further includes ablind pouch. The blind pouch functions to intermittently trap a smallportion of food or fluid there within. The trapped food or fluid acts toweigh down the distal end of the sleeve body, thereby keeping the sleevecomponent elongated. In one embodiment, the distal end of the sleeve isreinforced with at least a second layer to assist in keeping the distalend positioned downward and prevent it from folding up.

In one embodiment, the sleeve comprises a wire mesh configuration havinga plurality of nodes, similar to the configuration described above forthe wire mesh structure.

In another embodiment, the sleeve component comprises a membrane that isflexible and compressible by the contractions of the small intestine. Inone embodiment, the sleeve includes a minimum level of structure whichimparts upon the sleeve a minimum amount of structural strength toresist buckling from gastrointestinal forces and remain functional. Inone embodiment, the minimum level of structure comprises a singlestructure extending along at least 10% of a length of the sleeve toprovide the sleeve with linear strength. In various embodiments, thesingle structure is a straight wire, a wire helix, or a wire mesh. Inone embodiment, the membranous sleeve component comprises a plurality ofhorizontal and/or vertical support elements along the length of thesleeve body. In one embodiment, the horizontal elements include wirerings spaced apart along the length of the sleeve body. In variousembodiments, the rings are spaced between 2 and 24 inches apart. In oneembodiment, the rings are spaced 6 inches apart. In one embodiment, thevertical support elements include elongate metal wires. In variousembodiments, the wires are between 2 and 60 inches in length. In oneembodiment, the metal wires are 6 inches in length. In anotherembodiment, the membranous sleeve component comprises a spiral metalwire extending along its length. The spiral metal wire provides supportto the sleeve component and maintains its elongated shape. In variousembodiments, the spiral metal wire is comprised of a shape memory metal,such as Nitinol. The spiral metal wire must not be too tight such that,once the sleeve in compressed for delivery, it becomes kinked and cannotregain its full shape. In various embodiments, the spiral metal wire ofthe sleeve has a thickness of 0.1 to 1.0 mm. In one embodiment, thespiral metal wire of the sleeve has a thickness of 0.2 mm. As similarlydiscussed above with reference to the collar bend radius, the bendradius of the spiral metal wire of the sleeve should be such to create astrain percentage that will be in a range of 0.1 to 20%, and preferablyless than 8%. In various embodiments, the strain percentage (%) of thespiral metal wire can be defined by the following formula:

${{Strain}\mspace{14mu}\%} = {\frac{d}{2} \times \left\lbrack {\frac{1}{Rf} - \frac{1}{Ri}} \right\rbrack \times 100}$

wherein d is the diameter of the wire, Rf is the final bend radius, andRi is the initial bend radius. Therefore, in various embodiments, thespiral metal wire has a pitch in a range of 5 to 150 mm. In oneembodiment, the spiral metal wire has a pitch of 60 mm. In variousembodiments, the sleeve includes more than one spiral metal wire toprovide greater support while still preventing permanent kinking. In oneembodiment, the sleeve includes three spiral metal wires wherein eachindividual wire has a pitch of 60 mm and the wires are spaced such thatthe pitch between two separate wires is 20 mm. In another embodiment,the sleeve includes six spiral or helical wires to provide structuralsupport to the sleeve. In various embodiments, the membrane of thesleeve component extends proximally onto the lower portion of the wiremesh structure and covers all or a portion of said lower portion.

The sleeve is flexible and compressible such that during delivery it isrestrained in a compressed configuration on the distal end of a deliverydevice. In one embodiment, the sleeve telescopes into itself to shortenits length and facilitate delivery. In addition, when the device is inthe pre-deployment configuration, the sleeve can be folded onto itselfto shorten its length and assist with placement in a delivery device orcatheter. In various embodiments, the sleeve is folded 2 to 10 timesupon itself and then folded or wrapped along a delivery device orcatheter for delivery. In one embodiment, the sleeve is fed coaxiallyover a guidewire, a delivery device or catheter. In another embodiment,the sleeve is folded along the side or around a delivery device orcatheter. This helps prevent the sleeve from sticking to the guidewireand/or delivery device/catheter as the guidewire and deliverydevice/catheter are retracted, which is sometimes encountered when thesleeve has been fed coaxially over the guidewire or deliverydevice/catheter.

In other embodiments, some intragastric devices of the presentembodiment include a sleeve having a shorter length than the lengthsdescribed above. In various embodiments, the short sleeve has an overalllength of 100-120 mm. In various embodiments, the short sleeve has afunnel shape or cone shape. In some embodiments, the short sleevecomprises a wire formed into a wire mesh structure or braid having aplurality of nodes, similar to the configuration described above for thewire mesh structure. In one embodiment, the braid is created using asingle wire. In one embodiment, the wire is composed of a shape memorymetal. In one embodiment, the shape memory metal is Nitinol. In otherembodiments, the braid is created by machine braiding multiple wires. Insome embodiments, the pitch, or distance between nodes, is uniform. Inother embodiments, the pitch is variable. The ends of the braid aredesigned to be atraumatic. In one embodiment, the ends are blunted. Inanother embodiment, the ends are capped with a soft polymeric tip. Insome embodiments, a portion of the short sleeve is coated with acovering. In some embodiments, the covered portion comprises thefloating nodes. In one embodiment, the covering is silicone. In variousembodiments, the diameter of the proximal end of the sleeve isapproximately equal to the outer diameter of an anti-migration collar atthe distal end of a wire mesh structure. In such embodiments, theproximal end of the sleeve is fitted over and attaches to theanti-migration collar. In other embodiments, the diameter of theproximal end of the sleeve is smaller than the outer diameter of ananti-migration collar and approximately equal to the diameter of a neckof the collar connecting said collar to said wire mesh structure. Inthese embodiments, the proximal end of the sleeve is attached to saidneck of said collar.

In one embodiment, the number of nodes is uniform across the braid. Inone embodiment, the number of nodes is 24. In other embodiments, thenumber of nodes is variable across the braid. For example, in variousembodiments, the short sleeve braid includes 24 nodes at the proximalend and 18 or 12 nodes at the distal end. In these embodiments, thenodes comprising the difference in number of nodes between the two ends(for example, 6 or 12 nodes) are floating nodes and are positioned alongthe body of the short sleeve.

Once an intragastric device having a short sleeve is deployed, the shortsleeve intermittently engages and blocks a patient's pylorus withoutbeing anchored to the pylorus. This prevents food from passing throughthe pylorus and forces the food to pass through the short sleeve fromthe stomach and into the duodenum, thus regulating gastric outflow. Invarious embodiments, an opening at the distal end of the short sleeve is1-30 mm in diameter wherein the size of the diameter determines the rateof gastric outflow. In one embodiment, the opening can be 0 mm when thepylorus is engaged, thereby completely blocking outflow. Therefore, foodis allowed to enter the duodenum from the stomach only when the pylorusis not engaged or only partially engaged.

In various embodiments, the sleeve has a high coefficient of frictioncompared to sleeves of the prior art. In various embodiments, the sleevehas a coefficient of friction ranging from 0.01-0.45. In one embodiment,the sleeve has a coefficient of friction equal to or less than 0.10. Ithas been encountered with relatively smooth sleeves that, duringdeployment, the smooth sleeve can become stuck to the inside of adelivery catheter or stuck to itself, resulting in destruction of thesleeve as force is applied to free the sleeve. Therefore, a sleeve witha rougher outer surface can be easier to feed into a delivery device orcatheter and then deploy. In various embodiments, the sleeve includes amatte outer surface. In other embodiments, a particulate matter orrelatively rough substance, such as corn starch or biocompatible powder,is applied to the outer surface of the sleeve prior to loading thesleeve into a delivery device and deployment.

In various embodiments, the sleeve includes one or more radiopaquemarkers to ensure proper positioning of the sleeve using radiographicimaging. In various embodiments, the radiopaque markers include aplurality of individual markings along an outer surface of the sleevebody. In other embodiments, the radiopaque marker includes a single lineextending along an outer surface of the sleeve body. A spiraled singleline can indicate twisting of the sleeve. In still other embodiments,the radiopaque markers include a plurality of individual markings and asingle line extending along an outer surface of the sleeve body. Inother embodiments, no radiopaque markings are necessary as the wirethickness of the support elements of the sleeve is great enough to allowfor radiographic visualization.

Retrieval Mechanism

In various embodiments, the wire mesh structure or wire mesh structurewith coupled sleeve component includes one or more retrieval mechanismswith at least one retrieval mechanism positioned proximate the at leastone opening at the proximal end of the wire mesh structure. In oneembodiment, the retrieval mechanism comprises an 80 lb. break strengthrated retrieval suture.

Anti-Migration Component

In various embodiments, the wire mesh structure or wire mesh structurewith coupled sleeve component includes one or more anti-migrationcomponents or collars. In one embodiment, the anti-migration componentis comprised of a metal. In one embodiment, the metal is a shape memorymetal, such as Nitinol. The anti-migration component is preferablypositioned at the distal end of the wire mesh structure (at the junctionof the wire mesh structure with the sleeve component in the embodimentof the device including a sleeve) and, once the device is deployed,comes to rest proximal to the pylorus. The anti-migration componentfunctions to prevent passage of the wire mesh structure or entire devicethrough the pylorus. The anti-migration component is in the form of acollar, an open torus, or a surface of revolution generated by revolvinga semi-circle in three-dimensional space about an axis extending throughthe center of the wire mesh (spherical or elliptical) device or thecenter of the opening of the lower portion of the wire mesh device.

In various embodiments, various components of the device, including thewire mesh structure, retrieval mechanism, and/or anti-migrationcomponent are coated with a therapeutic drug to enhance functionality ofthe device.

In various embodiments, the wire mesh structure, hook, and/oranti-migration component include a radiopaque marker for radiographicvisualization to facilitate delivery and retrieval. In variousembodiments, the wire mesh structure, hook, and/or anti-migrationcomponent include an ultrasound marker for ultrasound visualization tofacilitate delivery and retrieval.

Delivery Device

The present specification also discloses various embodiments of adelivery device used to deploy an intragastric device in thegastrointestinal tract of a patient. An intragastric device is preloadedonto a delivery device which is then used to deliver the wire mesh ofthe intragastric device into the stomach and the sleeve of theintragastric device into the proximal small intestine.

In one embodiment, a delivery device comprises an elongate tubular bodyhaving a coaxial plunger and catheter and a plurality of handles. Thehandles are manipulated to deploy the sleeve and wire mesh structure ofthe intragastric device in multiple stages. In one embodiment, thetubular body includes a trigger which controls movement of the variouscomponents of the delivery device to effectuate intragastric devicedeployment.

In various embodiments, the intragastric device can be retrieved using astandard overtube, endoscope, and grasper.

The present invention is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention.

FIG. 1 is an illustration of an upper gastrointestinal system. Afterswallowing, food passes rapidly through the esophagus 111 into thestomach 112. There, it is digested for a period of time and undergoesthe process of dilution to an iso-osmotic concentration by grinding andmixing with gastric juices. The stomach 112 relaxes to accommodate thevolume of ingested food. As the stomach 112 gets filled with food thesensation of fullness or satiety is generated by stretch receptors inthe gastric wall and the person stops eating. The iso-osmotic food,known as chyme, then passes through the pylorus 113 into the duodenum114. Passage of chyme into the duodenum 114 results in the release ofenzyme rich pancreatic secretions from the pancreas 115 and bile saltrich biliary secretions from the liver 116. The biliary secretionstravel through the common bile duct 117 where they combine with thepancreatic secretions arriving through the pancreatic duct 118 and thetwo ducts combine to form the ampulla of vater 119. The ampulla of vater119 serves as the entry point for the secretions to be deposited intothe duodenum 114. In the jejunum 120, the mixing of pancreatic andbiliary secretions with the chyme results in the digestion of proteins,fats, and carbohydrates, which are then absorbed into the blood stream.

FIG. 2A is an illustration of a wire mesh structure 201 of anintragastric device in a post-deployment configuration with a proximallysloping anti-migration disc or collar 204 extending from or attached toits distal end, in accordance with one embodiment of the presentspecification. The wire mesh structure 201 comprises a three dimensionalporous structure having an internal volume. The wire mesh structure 201has an oval shape and includes a retrieval mechanism 203. In oneembodiment, the retrieval mechanism is a silk suture loop. In oneembodiment, the retrieval mechanism is an 80 lb. retrieval suture. Theanti-migration collar 204 is proximally sloping in that it comprises adistal portion of the wire mesh structure 201 that is folded such thatthe distally directed end of the wire mesh structure 201 is made topoint toward the proximal end of the wire mesh structure 201. In otherembodiments, the collar 204 comprises any curved/atraumatic structurepositioned circumferentially around the distal end of the wire meshstructure 201. The collar 204 helps prevent the wire mesh structure 201from entering and passing through the pylorus. In one embodiment, thewire mesh structure 201 includes a bulbous, predominantly spherical orovoid proximal end and an expanded distal end. In one embodiment, thedistal half of the structure is covered with a membrane to impede thepassage of food out of the structure 201, directing the food through adistal opening. In one embodiment, the structure 201 has an optionalanti-reflux valve at the proximal end and another optional valve at thedistal end. The valve at the distal end acts to control the flow ofchyme or partially digested food from the inside of the structure 201 tothe outside of the structure 201.

FIG. 2B is an illustration of a wire mesh structure 210 in apost-deployment configuration with a proximally curving anti-migrationcollar 214 formed at its distal end, in accordance with one embodimentof the present specification. The wire mesh structure 210 has an ovalshape with a proximal end and a distal end. The wire mesh structure 210includes a first opening 211 at its proximal end and a second opening219 at its distal end. The wire mesh structure 210 includes staggerednodes 216, 218 within its body to facilitate compression for deliveryand removal. The wire mesh structure 210 also includes a set ofstaggered nodes 217 at its proximal end. The staggered nodes 217 at theproximal end provide a location for grasping, thereby enhancing ease ofretrieval. The anti-migration collar 214 is formed from a continuationof the wire of the wire mesh structure 210 at its distal end. Theanti-migration collar 214 bends proximally, toward the body of the wiremesh structure 210, and its ends 215 are formed in a rounded fashion tobe atraumatic to body tissues. In various embodiments, the wire meshstructure 210 has no sharp edges, preventing the occurrence ofabrasions, and a radial force high enough to prevent any significant orpermanent deformation by gastric contractions and passage through thepylorus, but low enough such that the wire mesh structure 210 is not toorigid, allowing it to be affected by gastric contractions enough tofacilitate movement of food through the wire mesh structure 210. In someembodiments, the wire mesh structure can withstand a contractile forceup to 200 mm Hg without being completely compressed. The anti-migrationcollar 214 is defined by a surface of revolution generated by revolvinga semi-circle in three-dimensional space about an axis extending througha center of the second opening 219 of the lower portion of the wire meshdevice. The collar 214 is also defined by a diameter equal to or greaterthan 25 mm.

FIG. 2C is another illustration of a wire mesh structure, in accordancewith one embodiment of the present specification. In variousembodiments, the length of the wire mesh structure measured from aproximal end 222 to a distal end 224 of anti-migration collar 214 rangesfrom 169 mm to 180 mm. In some embodiments, the length measured from theproximal end 222 to a distal end 226 of the oval structure isapproximately 141 mm and the length of the anti-migration collar 214measured from a proximal end 228 to a distal end 224 of theanti-migration collar 214 ranges from 31 mm to 36 mm. In an embodiment,a length of a middle portion 230 of the oval structure is approximately109 mm measured from a distal end of a proximal set of nodes 233 to aproximal end of a distal set of nodes 239, while that of portion 232 is117 mm measured from a proximal end of the proximal set of nodes 233 toa distal end of a distal set of nodes 239. Also, in an embodiment,lengths of a proximal portion 234 extending from said proximal end 222to said proximal end of said proximal set of nodes and a distal portion236 extending from said distal end of said distal set of nodes 239 tosaid distal end 226 of the oval structure are 12 mm. In otherembodiments, length of portion 232 ranges between 114 mm and 129 mm,while the lengths of proximal and distal portions 234, 236 of the ovalstructure ranges from 8 mm to 12 mm and 7 mm to 14 mm respectively. Inembodiments, an inner diameter 238 of anti-migration collar 214,defining an opening at the distal end 224 of the device, ranges from 27mm to 35 mm while an outer diameter 240, defining the outer limit of theanti-migration collar 214, ranges from 58 mm to 77 mm. Further, in someembodiments, the diameter of the wire mesh structure at a center widestpart of the oval structure ranges from 116 mm to 123 mm. In embodiments,a diameter of a circular opening 250 at the proximal end 222 ranges from17 mm to 20 mm.

As explained with reference to FIGS. 2A and 2B, the wire mesh structurecomprises a plurality of openings or gaps 242 forming the mesh. In someembodiments, the gaps 242 are diamond shaped as a result of thecrisscrossing pattern of the wire of the wire mesh structure. In anembodiment, a width 244 of the gaps 242 in the middle portion 230 of themesh ranges from 9.6 mm to 9.7 mm while a length 246 is 16 mm. Invarious embodiments, individual pieces of wire, such as wire piece 248,are joined together using processes such as riveting or crimping to formthe wire mesh structure. In some embodiments, the length of wire piece248 ranges from 5 mm to 5.5 mm and its diameter is approximately 1 mm.

In embodiments, as explained with reference to FIGS. 2C and 2H, the wiremesh structure comprises a plurality of loops formed in the wires of themesh proximal end 222, distal end 224 of anti-migration collar 214, anddistal end 236 of the oval structure. In some embodiments, a thicknessof the wire forming the loops, such as wire loop 252 shown in FIGS. 2Eand 2F, is approximately 0.4 mm, the diameter of the circular portion254 of wire loop 252 is approximately 2 mm, and a thickness 256 of theloop 252 is approximately 1 mm. In an embodiment, the distal end 224 ofanti-migration collar 214 comprises 9 loops such as the wire loop 252shown in FIGS. 2E and 2F.

FIGS. 3A and 3B are illustrations depicting a plurality of free ends ornodes 301, 302 positioned at a proximal end and a distal end of a wiremesh structure, in accordance with one embodiment of the presentspecification. Nodes 301 are positioned at the proximal end of a wiremesh structure and nodes 302 are positioned at a distal end of a wiremesh structure. The nodes comprise bends or curves in the wires of thewire mesh structure which are unsupported or not connected to otherportions of the wire mesh. In other words, the nodes are the loops orbends comprising the free ends at each end of the wire mesh structure.Each wire mesh structure comprises at least two pluralities of nodes,one plurality of nodes 301 at its proximal end and at least oneplurality of nodes 302 at its distal end. Other wire mesh structureembodiments, for example, those discussed with reference to FIGS. 3C and3D below, comprise more than two pluralities of nodes which impartsgreater compressibility to the wire mesh structures. Such wire meshstructures include free ends or nodes at each end of the structure plusfree ends or nodes positioned at lateral locations along the body lengthof the structure.

FIG. 3C is an illustration depicting a plurality of overlapping nodes303 positioned at one end of a wire mesh structure, in accordance withone embodiment of the present specification. As depicted in FIG. 3C, thenodes 303 are all positioned at the same lateral location. This createsa bulge in said lateral location when the wire mesh structure iscompressed into its pre-deployment configuration. The bulge creates dragforce on a delivery device or catheter during delivery of the wire meshstructure. FIG. 3D is an illustration depicting a first plurality ofnodes 304 positioned at one end of a wire mesh structure and a secondplurality of nodes 305 positioned proximal to the first plurality ofnodes 304, in accordance with one embodiment of the presentspecification. The two pluralities of nodes 304, 305 are staggeredacross two different lateral locations in FIG. 3D. The staggering ofnodes results in a smaller bulge when the wire mesh structure iscompressed into its pre-deployment shape, resulting in less drag forceapplied to a delivery device or catheter and therefore easier deliveryand retrieval of the wire mesh structure.

FIG. 3E is an illustration of first and second pluralities of nodes 306,307 at an end of a wire mesh structure, depicting loops 308 formed inthe wires of the first plurality 306 in accordance with one embodimentof the present specification. Referring to FIG. 3E, the loops 308 extendin a direction toward the center of the wire mesh structure. In otherembodiments, the loops extend outward in a direction away from thecenter of the wire mesh structure. In some embodiments, the loops 308serve as attachment points for other device components, for example, asleeve component, as further discussed with reference to FIGS. 4B and4C.

FIG. 3F is an illustration of first and second pluralities of nodes 316,317 at an end of a wire mesh structure, depicting loops 318 formed inthe wires of the second plurality 317 in accordance with one embodimentof the present specification. FIG. 3G is an illustration of first andsecond pluralities of nodes 310, 319 at an end of a wire mesh structure,depicting loops 313, 314 formed in alternating wires of both the first310 and second 319 pluralities, in accordance with one embodiment of thepresent specification. The wire loop embodiments depicted in FIGS. 3Ethrough 3G disclose various options for node looping and are notintended to be limiting. In various embodiments, any number orpercentage of the wires of a first plurality of nodes, a secondplurality of nodes, or both a first and second plurality of nodes, maybe looped. For example, in one embodiment, only the outermost nodes,with respect to a center of the wire mesh structure, are looped. Inanother embodiment, only the nodes just proximal to the outermost nodesare looped. In some embodiments, a percentage between 0 and 100% of thenodes are looped. In one embodiment, 50% of the nodes are looped. Inanother embodiment, 30% of the nodes are looped.

FIG. 3H is an illustration depicting a wire mesh structure 315 having afirst plurality of nodes 311 at its proximal end and a second pluralityof nodes 312 at its distal end, in accordance with one embodiment of thepresent specification. The wire mesh structure 315 of FIG. 3H includesthe fewest plurality of nodes possible (two) and will have the largestbulges at its proximal and distal ends when compressed into itspre-deployment configuration. FIG. 3I is an illustration depicting awire mesh structure 320 having first and second pluralities of nodes321, 322 at its proximal and distal ends respectively, and third 323 andfourth 324 pluralities of nodes distributed along its surface, inaccordance with one embodiment of the present specification. Theincreased number of pluralities of nodes allows for fewer individualnodes to be positioned at the lateral location of each plurality. Assuch, when compressed, the wire mesh structure will comprise a bulge ateach lateral location of each plurality of nodes but each bulge will besmaller in diameter than the bulges at the proximal and distal endscreated when the wire mesh structure seen in FIG. 3H is compressed.Therefore, the compressed pre-deployment configuration of the wire meshstructure of FIG. 3I will create less drag force on a delivery device orcatheter and will be easier to deploy. Although four pluralities ofnodes 321, 322, 323, 324 are depicted in the wire mesh structure 320 ofFIG. 3I, a wire mesh structure can have three or more than fourpluralities of nodes. In various embodiments, the wire mesh structureincludes 2 to 60 pluralities of nodes positioned at different laterallocations.

FIG. FIGS. 3J to 3N are illustrations depicting various possible nodeshapes in accordance with multiple embodiments. Possible node shapesinclude, but are not limited to, a sharp bend 331, a shallow bend 332, apointed bend 333, a circular bend 334, and a shape similar to an end ofa safety pin 335, including a wire loop 345 at the end of the node.

FIG. 4A is a close-up illustration of an atraumatic anti-migrationcollar 414 of a wire mesh structure 410 of an intragastric device 400,in accordance with one embodiment of the present specification. Theanti-migration collar 414 has a toroid bulb shape and comprises roundedends 415 which extend proximally toward the wire mesh structure 410. Therounded ends 415 are designed to be atraumatic to body tissues. Asdiscussed above, in some embodiments, the ends 415 are separated intovarious nodes to prevent bunching of the wires when compressed, whichcould lead to erosions. The long axis of the collar 412 is curved at anangle 413 greater than 90° compared to the long axis of the mesh 411such that the rounded ends 415 are pointing in the direction toward thewire mesh structure 410.

FIG. 4B is a close-up illustration of an atraumatic anti-migrationcollar 424 of a wire mesh structure 421 of an intragastric device 420,in accordance with another embodiment of the present specification. Theanti-migration collar 424 has a toroid bulb shape and comprises roundedends 425 which extend proximally toward the wire mesh structure 421. Therounded ends 425 are designed to be atraumatic to body tissues. In someembodiments, the ends 425 are separated into various nodes 427 l, 427 sto prevent bunching of the wires when compressed, which could lead toerosions. The nodes include long nodes 427 l and short nodes 427 s,wherein the long nodes 427 l extend further in a proximal direction backtoward the top of the wire mesh structure 421 than the short nodes 427s. In some embodiments, the collar 424 includes 9 long nodes 427 l and 9short nodes 427 s. The free ends of the long nodes 427 l include hoops428 for suturing a proximal end of a sleeve component. The hoops 428extend outward away from the free ends of the long nodes 427 l. In oneembodiment depicted in FIG. 4C, hoops 428 a are formed from twisting thefree ends of the long nodes 427 l into a hoop shape. In anotherembodiment depicted in FIG. 4D, hoops 428 b comprise separate wire hoopsthat are sutured to the free ends of the long nodes 427 l. In someembodiments, once the sleeve is attached, additional suture knots areplaced at the junction of the twist or separate wire hoop to preventsliding of the sleeve attachment.

FIG. 4E is a close-up illustration of an atraumatic anti-migrationcollar 434 of a wire mesh structure 431 of an intragastric device 430,in accordance with yet another embodiment of the present specification.The anti-migration collar 434 has a toroid bulb shape and comprisesrounded ends 435 which extend proximally toward the wire mesh structure431. The rounded ends 435 are designed to be atraumatic to body tissues.In some embodiments, the ends 435 are separated into various nodes 4371,437 s to prevent bunching of the wires when compressed, which could leadto erosions. The nodes include long nodes 4371 and short nodes 437 s,wherein the long nodes 4371 extend further in a proximal direction backtoward the top of the wire mesh structure 431 than the short nodes 717s. In some embodiments, the collar 434 includes 9 long nodes 437 l and 9short nodes 437 s. The free ends of the long nodes 437 l include hoops439 for suturing a proximal end of a sleeve component. The hoops 439extend inward toward the curve at the distal end of the wire meshstructure 431. In one embodiment shown in FIG. 4F, hoops 439 a areformed from looping the free ends of the long nodes 4371 into a hoopshape. In another embodiment depicted in FIG. 4G, hoops 439 b compriseseparate wire hoops that are sutured to the free ends of the long nodes437 l. In some embodiments, once the sleeve is attached, additionalsuture knots are placed at the junction of the loop or separate wirehoop to prevent sliding of the sleeve attachment.

In some embodiments, a sleeve component is attached to the distal end ofthe wire mesh structure or the collar of the intragastric device. Invarious embodiments, the sleeve component of the present specificationis made of polytetrafluoroethylene (PTFE) or polyethylene or cast PTFE(e.g., Teflon), PTFE with fluorinated ethylene propylene (FEP) orperfluoroalkoxy (PFA) coating, PFA, extruded FEP and extruded PFA orextruded PTFE or a fluoropolymer or silicone. In one embodiment, asilicone sleeve is manufactured by hand pouring and braiding. In anotherembodiment, a silicone sleeve is manufactured by machine braiding. Invarious embodiments, the sleeve component has a length in a range of 6inches to 6 feet or longer. In one embodiment, the sleeve component hasa length of 24 inches. In another embodiment, the sleeve component has alength of 30 inches. In various embodiments, the sleeve component has adiameter in a range of 1 cm to 10 cm. In one embodiment, the sleevecomponent has a diameter of 3 cm.

FIG. 5A is an illustration of a portion of a sleeve component 500 of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting a singlewire support 501 spiraling along the body of the sleeve 500. The metalwire needs to have a tight enough spiral to provide support but must notbe too tight such that, once the sleeve in compressed for delivery, itbecomes kinked and cannot regain its full shape. Referring to FIG. 5A,the spiral metal wire 501 has a pitch depicted by length/which is equalto 60 mm. With a wire thickness of 0.1 to 1 mm, this pitch gives thespiral metal wire a strain percentage that will be no more than 20%, andpreferably less than 8%.

FIG. 5B is an illustration of a portion of a sleeve component 505 of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting multiplewire supports 506, 507, 508 spiraling along the body of the sleeve 505.The sleeve includes more than one spiral metal wire to provide greatersupport while still preventing permanent kinking. Referring to FIG. 5B,each individual wire 506, 507, 508 has a pitch depicted by length l₁which is equal to 60 mm. The wires 506, 507, 508 are spaced such thatthe pitch between two separate wires, depicted by length l₂, is equal to20 mm.

FIG. 5C is an illustration of a funnel shaped sleeve component 510 of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting spiral wireloop supports 511, 513 on the sleeve 510. In the embodiment depicted inFIG. 5D, the sleeve 510 includes two sets of wire loop supports 511,513. Each set of wire loop supports 511, 513 includes a loop comprisingtwo individual wires, for a total of four wires on the sleeve 510. Eachwire loop support 511, 513 is finished with blunted ends 515 to beatraumatic to body tissues. The wire loop supports 511, 513 are twistedinto a spiral configuration and looped along the length of the sleeve510. In one embodiment, the pitch, or distance between each loop 511,513 (and between each wire of each loop 511, 513) is defined by length land is approximately 15 mm.

FIG. 5E is an illustration of a sleeve component 520 of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting a funnel shapedopening 521 at the proximal end of the sleeve. The funnel shaped opening521 is well suited for attachment to the nodes of the collar positionedat the distal end of the wire mesh structure of some embodiments of theintragastric device of the present specification, as discussed in detailwith references to FIGS. 11C and 11D below.

FIG. 5F is an illustration of a funnel shaped sleeve component 525 of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting a pluralityof markings 527 on an outer surface of the sleeve body. The markings 527are radiopaque and their radiographic visualization assists properplacement of the sleeve during device delivery.

FIG. 5G is an illustration of a funnel shaped sleeve component 530 of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting a markingline 533 extending along the length of the sleeve 530 on an outersurface of the sleeve body. The line 533 is radiopaque and itsradiographic visualization assists proper placement of the sleeve duringdevice delivery. In addition, spiraling or rotation of the line about acenter axis of the sleeve can indicate twisting of the sleeve.

FIG. 5H is an illustration of a funnel shaped sleeve component 535 of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting a pluralityof markings 537 and a marking line 538 extending along the length of thesleeve 535 on an outer surface of the sleeve body. The markings 537 andthe line 538 are radiopaque and their radiographic visualization assistsproper placement of the sleeve during device delivery and help to detecttwisting of the sleeve 535.

FIG. 6A is a cross-sectional illustration of a funnel shaped sleevecomponent 600 of an intragastric device in a post-deploymentconfiguration in accordance with one embodiment of the presentspecification, depicting a plurality of sleeve layers 606, 607, 608,609. In one embodiment, the sleeve layers 606, 607, 608, 609 arecomprised of PTFE. The sleeve 600 includes an innermost first layer 606which is approximately 0.06 mm thick and extends in a configurationalong the length of the sleeve. The first layer 606 extends along theentire length of the sleeve 600. The sleeve 600 includes a second layer607, overlaying said first layer 606, which is approximately 0.06 mmthick and extends only along a proximal portion 616 of the sleeve 600and a distal portion 618 of the sleeve 600. In one embodiment, theproximal portion 616 includes a funnel portion 601 and an additionalportion having a length l₁ which extends approximately 30-40 mm distallybeyond said funnel portion 601. In one embodiment, the sleeve 600includes a distal end having a length l₂ of approximately 20-30 mm. Thedistal portion 618 comprises approximately only the most proximal 10 mmof length l₂. In one embodiment, the second layer 607 extends in aconfiguration along the width of the sleeve 600. The sleeve 600 includesa third layer 608, overlaying said second layer 607 and a center portion617 of said first layer 606. The third layer 608 is approximately 0.06mm thick and extends in a configuration along the width of the sleeve600. The sleeve 600 includes a fourth layer 609, overlaying said thirdlayer 608, which is approximately 0.06 mm thick and extends in aconfiguration along the length of the sleeve 600. Therefore, in theembodiment depicted in FIG. 6A, the sleeve 600 comprises four layers atits proximal section 616, three layers at its center section 617, andfour layers at its distal section 618. The layers 606, 607, 608, 609 arecross-layered bonded, or applied in different configurations (along thelength versus along the width of the sleeve 600), to give the sleeveadded durability. In one embodiment, the sleeve 600 further includesmetal wire supports 605 between the second layer 607 and the third layer608 (or between the first layer 606 and the third layer 608 in thecenter portion 617 of the sleeve 600) to provide structural support. Inone embodiment, the sleeve includes suture points 619 for connection toa wire mesh structure.

FIG. 6B is a cross-sectional illustration of a funnel shaped sleevecomponent 620 of an intragastric device in a post-deploymentconfiguration in accordance with another embodiment of the presentspecification, depicting a plurality of sleeve layers 626, 627, 628,629, 630. In various embodiments, the sleeve layers 626, 627, 628, 629,630 are comprised of any one or combination of polytetrafluoroethylene(PTFE), low-density polyethylene (LDPE), high-density polyethylene(HDPE), and ultra-high-molecular-weight polyethylene (UHMWPE). In oneembodiment, the sleeve 620 includes an innermost first PTFE layer 626which is approximately 0.06 mm thick and extends in a configurationalong the length of the sleeve. The first PTFE layer 626 extends alongthe entire length of the sleeve 620. The sleeve 620 includes a secondPTFE layer 627, overlaying said first PTFE layer 626, which isapproximately 0.06 mm thick and extends only along a proximal portion636 of the sleeve 620 and a distal portion 638 of the sleeve 620. In oneembodiment, the proximal portion 636 includes a funnel portion 621 andan additional portion having a length l₁ which extends approximately30-40 mm distally beyond said funnel portion 621. In one embodiment, thesleeve 620 includes a distal end having a length l₂ of approximately20-30 mm. The distal portion 638 comprises approximately only the mostproximal 10 mm of length l₂. In one embodiment, the second PTFE layer627 extends in a configuration along the width of the sleeve 620. Thesleeve 620 includes a PTFE third layer 628, overlaying said second PTFElayer 627 and a center portion 637 of said first PTFE layer 626. Thethird PTFE layer 628 is approximately 0.06 mm thick and extends in aconfiguration along the width of the sleeve 620. The sleeve 620 includesa fourth PTFE layer 629, overlaying said third PTFE layer 628, which isapproximately 0.06 mm thick and extends in a configuration along thelength of the sleeve 620. In one embodiment, the sleeve further includesa fifth PFTE layer 630 sandwiched between the third PTFE layer 628 andthe fourth PTFE layer 629. In one embodiment, the fifth PTFE layer 630is approximately 0.06 mm thick and extends in a configuration along thelength of the sleeve 620. Therefore, in the embodiment depicted in FIG.6B, the sleeve 620 comprises five total layers at its proximal section636, four total layers at its center section 637, and five total layersat its distal section 638. In various embodiments, the layers 626, 627,628, 629, 630 are cross-layered bonded, or applied in differentconfigurations (along the length versus along the width of the sleeve620), to give the sleeve added durability. In one embodiment, the sleeve620 further includes metal wire supports 625 between the second PTFElayer 627 and the third PTFE layer 628 (or between the first PTFE layer626 and the third PTFE layer 628 in the center portion 637 of the sleeve620) to provide structural support. In one embodiment, the sleeveincludes suture points 639 for connection to a wire mesh structure.

FIG. 6C is a cross-sectional illustration of a funnel shaped sleevecomponent 640 of an intragastric device in a post-deploymentconfiguration in accordance with one embodiment of the presentspecification, depicting a plurality of sleeve layers 643, 644, 646,647, 648, 649, 650. In various embodiments, the sleeve layers 643, 644,646, 647, 648, 649, 650 are comprised of any one or combination ofpolytetrafluoroethylene (PTFE), low-density polyethylene (LDPE),high-density polyethylene (HDPE), and ultra-high-molecular-weightpolyethylene (UHMWPE). In one embodiment, the sleeve 640 includes aninnermost first PTFE layer 643 which is approximately 0.06 mm thick andextends in a configuration along the length of the sleeve. The firstPTFE layer 643 extends along the entire length of the sleeve 640. Thesleeve 640 includes a second PTFE layer 644, overlaying said first PTFElayer 643, which is approximately 0.06 mm thick and extends only along aproximal portion 656 of the sleeve 640 and a distal portion 658 of thesleeve 640. In one embodiment, the proximal portion 656 includes afunnel portion 641 and an additional portion having a length l₁ whichextends approximately 30-40 mm distally beyond said funnel portion 641.In one embodiment, the sleeve 640 includes a distal end having a lengthl₂ of approximately 20-30 mm. The distal portion 658 comprisesapproximately only the most proximal 10 mm of length l₂. In oneembodiment, the second PTFE layer 644 extends in a configuration alongthe width of the sleeve 640. The sleeve 640 includes a third PTFE layer646, overlaying said second PTFE layer 644 and a center portion 657 ofsaid first PTFE layer 643. The third PTFE layer 646 is approximately0.06 mm thick and extends in a configuration along the width of thesleeve 640. The sleeve further includes a first intermediate PFTE layer648 and a second intermediate PFTE layer 649 sandwiched between thesecond PTFE layer 644 and the third PTFE layer 646. In one embodiment,the first intermediate PFTE layer 648 and second intermediate PFTE layer649 are both approximately 0.06 mm thick. In one embodiment, the firstintermediate PFTE layer 648 and second intermediate PFTE layer 649 bothextend in a configuration along the length of the sleeve 640. In anotherembodiment, the first intermediate PFTE layer 648 and secondintermediate PFTE layer 649 both extend in a configuration along thewidth of the sleeve 640. In another embodiment, the first intermediatePFTE layer 648 extends in a configuration along the length of the sleeve640 and the second intermediate PFTE layer 649 extends in aconfiguration along the width of the sleeve 640. In yet anotherembodiment, the first intermediate PFTE layer 648 extends in aconfiguration along the width of the sleeve 640 and the secondintermediate PFTE layer 649 extends in a configuration along the lengthof the sleeve 640. The sleeve 640 includes a fourth PTFE layer 647,overlaying said third PTFE layer 646, which is approximately 0.06 mmthick and extends in a configuration along the length of the sleeve 640.The sleeve further includes a third intermediate PFTE layer 650sandwiched between the third PTFE layer 646 and the fourth PTFE layer647. In one embodiment, the third intermediate PFTE layer 650 isapproximately 0.06 mm thick and extends in a configuration along thelength of the sleeve 640. Therefore, in the embodiment depicted in FIG.6C, the sleeve 640 comprises seven total layers at its proximal section656, six total layers at its center section 657, and seven total layersat its distal section 658. In various embodiments, the layers 643, 644,646, 647, 648, 649, 650 are cross-layered bonded, or applied indifferent configurations (along the length versus along the width of thesleeve 640), to give the sleeve added durability. In one embodiment, thesleeve 640 further includes metal wire supports 645 between the firstintermediate PFTE layer 648 and the second intermediate PFTE layer 649to provide structural support. In one embodiment, the sleeve includessuture points 659 for connection to a wire mesh structure.

While FIGS. 6A through 6C depict sleeves having multiple PTFE layers,these configurations are not intended to be limiting and other sleeveembodiments are envisioned having more or fewer PTFE layers or layerscomprising other materials with varied stacking of the individuallayers.

FIGS. 6D and 6E are cross-sectional illustrations of a funnel shapedsleeve component 660 of an intragastric device in a post-deploymentconfiguration depicting a plurality of sleeve layers. The sleeveincludes a cylindrical portion 660 c and a funnel shaped portion 660 f.In some embodiments, the cylindrical portion 660 c has a length l_(c) ofapproximately 500 mm and the funnel portion has a length l_(f) ofapproximately 100 mm. The sleeve component 660 of FIG. 6F is comprisedof a single machine braided wire 661 sandwiched between multiple sleevelayers. In one embodiment, the single machine braided wire 661 is in anaxially stretched configuration. The single machine braided wire 661extends along only a proximal portion of the cylindrical portion 660 cof the sleeve 660. In one embodiment, approximately 450 mm of theproximal portion of the cylindrical portion 660 c of the sleeve 660includes the single machine braided wire 661 while at least 50 mm at thedistal end of the sleeve 660 contains no wire. In one embodiment, thedistal end of the sleeve 660 includes a distal opening 682 having adiameter of approximately 24.5 mm. The funnel portion 660 f includes awire support 671 ending proximally in a plurality of nodes 672. In oneembodiment, the sleeve 660 includes a total of 18 nodes equidistant fromone another and comprising alternating long and short nodes as describedabove. In some embodiments, the sleeve layers extend proximally beyondthe long nodes a distance of at least 5 mm. In one embodiment, theproximal end of the sleeve 660 includes a proximal opening 681 having adiameter of approximately 63 mm. In various embodiments, the singlemachine braided wire 661 and wire support 671 each comprise a wirehaving a diameter in a range of 0.100 to 0.150 mm. In one embodiment,the single machine braided wire 661 and wire support 671 each comprise awire having a diameter of 0.127 mm. In another embodiment, the singlemachine braided wire 661 and wire support 671 each comprise a wirehaving a diameter of 0.140 mm.

The sleeve 660 includes an innermost first PTFE layer 662 which extendsin a configuration along the width of the sleeve 660. The first PTFElayer 662 extends along the entire length of the sleeve 660. In oneembodiment, the first PTFE layer 662 has a thickness of approximately0.06 mm. The single machine braided wire 661 overlays said first PTFElayer 662 along the proximal portion of said cylindrical portion 660 cand the wire support 671 overlays the first PTFE layer 662 along thefunnel portion 660 f of the sleeve 660. A proximal intermediate PFTElayer 663 p overlays the wire support 671 along the funnel portion 660 fand extends distally approximately 5 to 7 mm over the single machinebraided wire 661 of the cylindrical portion 660 c of the sleeve 660. Adistal intermediate PFTE layer 663 d overlays the first PFTE layer 662at the distal end of the sleeve and extends proximally approximately 5to 7 mm over the single machine braided wire 1601 of the cylindricalportion 660 c of the sleeve 660. A plurality of cylindrical intermediatePFTE layers 663 c overlay the single machine braided wire 661 alongsections of the cylindrical portion of the sleeve 660. In someembodiments, the sleeve 660 includes three cylindrical intermediate PFTElayers 663 c, each having a length of approximately 3 to 5 mm and spaced70 to 80 mm from one another and from the proximal intermediate PFTElayer 663 p and distal intermediate PFTE layer 663 d at the proximal anddistal ends of the sleeve respectively. The sleeve 660 includes anoutermost second PTFE layer 664 which is approximately 0.06 mm thick andextends in a configuration along the length of the sleeve 660.

In some embodiments, the sleeve 660 further includes at least one markerfor visualization upon radiographic inspection to determine properplacement after delivery. Referring to FIG. 6E, the sleeve includesthree markers 665 positioned proximate a proximal end of the singlemachine braided wire 661, proximate a center of the single machinebraided wire 661, and proximate a distal end of the single machinebraided wire. In one embodiment, each marker 665 is covered and held inplace by a patch of PTFE 666 having a length of approximately 5 mm, awidth of approximately 5 mm, and a thickness of approximately 0.06 mm.In one embodiment, the markers 665 are separated from one another by adistance of approximately 145 mm to 155 mm. In one embodiment, themarkers 665 are positioned at every alternate cylindrical intermediatePFTE layer 663 c. In one embodiment, the markers 665 are positioned onone side of the sleeve 660. In one embodiment, the markers 665 aretantalum markers.

Referring to FIGS. 6A through 6F, in various embodiments, the sleevelayers comprised of PTFE can also be comprised of polyethylene (PE),low-density polyethylene (LDPE), high-density polyethylene (HDPE), andultra-high-molecular-weight polyethylene (UHMWPE). As an alternate tobeing bonded, the sleeve layers may be sutured.

FIG. 6G is a cross-sectional illustration of a funnel shaped sleevecomponent 690 of an intragastric device in a post-deploymentconfiguration in accordance with yet another embodiment of the presentspecification. Referring to FIG. 6E, the sleeve 690 includes a proximalfunnel shaped portion 690 p and a distal cylindrically shaped portion690 d. The proximal portion 690 p comprises a hand-braided Nitinol wiremesh 691 covered with PTFE. The distal portion 690 d comprises amachine-braided Nitinol wire mesh 692 covered with PTFE. The distalportion 690 d also includes at least one fluoropolymer band 695 overlaidfor improved bonding of the Nitinol wire mesh with the PTFE. At leastone radiopaque marker band 693 is also included in the distal portion690 d.

FIG. 6H is an illustration of a stent support 680 for a sleeve componentof an intragastric device, in accordance with one embodiment of thepresent specification. In the pictured embodiment, the stent support 680includes a plurality of rings 683 formed from CZ′ shape segments ofwire. In another embodiment, the stent support comprises a continuousspiral wire support wherein wires of the spiral are configured into ‘Z’shapes. In one embodiment, the stent support 680 has a shape similar tothe pattern 2033 depicted in FIG. 20F. Referring again to FIG. 6H, inone embodiment, each ring 683 is connected by a straight wire 684, suchthat a space 685 exists between each ring 683 which will comprise onlythe remaining layers of the sleeve component. In some embodiments, eachring 683 has length in a range of 1-2 cm. In some embodiments, eachconnecting straight wire 684 has a length in a range of 1-2 inches andeach space 685 also has a length in a range of 1-2 inches. In oneembodiment, the proximal end of the stent support 680 includes a funnelshaped ring segment 686. In one embodiment, the funnel shaped ringsegment 686 includes a sutured connection 687 to the first distal ring683 a. In various embodiments, the funnel shaped ring segment 686 has adiameter sized to match the diameter of an anti-migration component atthe distal end of a wire mesh structure to which it will be attached.

FIG. 6I is an illustration of a sleeve component 688 of an intragastricdevice having the stent support 680 of FIG. 6H. The stent support 680includes rings 683 connected by straight wires 684. The other layers689, such as PTFE, of the sleeve component 688 are depicted between eachset of rings 683. The ‘Z’ shaped stent support 680 provides the sleevecomponent 688 with structural integrity such that it will not collapseas a result of intestinal contractions while still allowing the sleevecomponent 688 to be flexible enough to conform to the curves of thegastrointestinal tract.

In an embodiment, the sleeve and wire mesh of the present gastric wiremesh device may be covered with a web in order to make the sleeveportion flexible and kink resistant, while at the same time controllingthe porosity of the device. In an embodiment, the web is producedthrough electrospinning PTFE into polymeric fibers with extremely smallthickness ranging from 0.10 nanometers to 100 microns. Electrospinningallows materials to possess high surface-to-weight and volume ratioswhile still maintaining excellent mechanical properties. It is similarin nature to expanded PTFE, but with a lower basis weight and hascomparable chemical and temperature resistance. If a strand of the webbreaks, it can be easily repaired. In an embodiment, a first web layeris webbed over a sleeve of an intragastric device. Then, a scaffoldingfollowed by a second web layer is placed over the first web layer toform an outer layer, thus encapsulating the nitinol or polymer scaffold.

In an embodiment, the mesh device of the present specification maycomprise a braided sleeve or over-braid that is both expandable andflexible for aerospace, automotive and medical markets created by usingdrawn fibers. The woven braiding guards against chaffing and providesadditional chemical wear resistance and flexibility to a sleeve of thepresent wire mesh device. In embodiments, the drawn fiber may be aperfluoroalkoxy (PFA) drawn fiber, fluorinated ethylene propylene (FEP)drawn fiber, ethylenetetrafluoroethylene (ETFE) drawn fiber,polyetheretherketone (PEEK) drawn fiber, polyvinylidene fluoride (PVDF)drawn fiber or ethylene chlorotrifluoroethylene (ECTFE) drawn fiber. Inan embodiment, a high temperature resistant nano-fiber membrane, whichhas the ability to capture greater than 0.1 micron-sized particles, maybe used to cover the wire mesh device of the present specification. FIG.6H illustrates a portion 603 of a sleeve of a wire mesh device coveredwith a nano-fiber membrane 605, in accordance with an embodiment of thepresent specification.

FIG. 7 is an illustration of a funnel shape sleeve 700 for anintragastric device, in accordance with one embodiment of the presentspecification. The sleeve 700 has a funnel shape with a diameter thatdecreases as the sleeve extends from a first opening 713 at its proximalend to a second opening 719 at its distal end. The sleeve 700 comprisesat least one wire 702 folded about itself to create the funnel shapewith a crisscross weave pattern. As the sleeve 700 extends distally, itsdiameter decreases and the intersections of the wire of the crisscrossweave become positioned closer together. The sleeve 700 includes curves,or free ends, at its proximal end and distal end. The free ends aredesigned to be atraumatic to body tissues. In some embodiments, thefirst opening 713 has a diameter that is substantially equal to orslightly greater than a diameter of an anti-migration collar of a wiremesh structure. The sleeve 700 is slid over an anti-migration collar andthen secured in place by suturing free ends 714 at the proximal end ofthe sleeve to nodes comprising the anti-migration collar. The free ends718 at the distal end of the sleeve 700 circumscribe the second opening719. In various embodiments, the sleeve 700 is a short sleeve having atotal length in a range of 1 cm-120 cm. In one embodiment, the sleeve700 is a short sleeve having a total length of 10 cm. In the picturedembodiment, the conical funnel section comprises 100% of the sleevelength.

FIG. 8 is an illustration of a funnel shape sleeve 800 for anintragastric device, in accordance with another embodiment of thepresent specification. The sleeve includes a proximal end with a firstopening 813 and a distal end with a second opening 819. The sleeve 800further includes a proximal portion 811 and a distal portion 816. Boththe proximal portion 811 and the distal portion 816 of the sleeve 800are funnel shaped, each having a diameter that decreases as the portions811, 816 extend distally. The diameter of the proximal portion 811 isgreatest at the proximal end of the sleeve 800, at the position of thefirst opening 813, and decreases as the proximal portion 811 extendsdistally until the sleeve 800 transitions into its distal portion 816 ata transition point 803. At the transition point 803, the diameters ofthe proximal portion 811 and the distal portion 816 are equal. Thediameter of the distal portion 816 then decreases as said distal portion816 extends distally. In another embodiment, the diameter of the distalportion remains the same along its length. In yet another embodiment,the diameter of the distal portion increases as it extends distally. Thedistal portion 816 of the sleeve 800 ends in a second opening 819 at adistal end of the intragastric device 800. The proximal portioncomprises a first wire 802 folded upon itself to create a funnel shapewith a first crisscross weave pattern. The distal portion comprises asecond wire 812 folded upon itself to create a funnel shape with asecond crisscross weave pattern. In some embodiments, the second wire812 is an extension of the first wire 802. In other embodiments, thefirst wire 802 and second wire 812 are separate wires which are joinedtogether at the transition point 803. In one embodiment, the separatewires are spot welded together. In both the proximal 811 and distalportions 816, the intersecting sections of the wires come closer to oneanother as the portions 811, 816 extend distally and the funnel shapenarrows, such that the weave pattern becomes tighter at the distal endsof each portion 811, 816. In one embodiment, the proximal portion 811has the same weave pattern as the distal portion 816. In anotherembodiment, the weave pattern of the proximal portion 811 is tighterthan the weave pattern of the distal portion 816. In another embodiment,the weave pattern of the distal portion 816 is tighter than the weavepattern of the proximal portion 811.

In one embodiment, the proximal portion 811 has a length equal to alength of the distal portion 816. In another embodiment, the proximalportion 811 has a length that is less than a length of the distalportion 816. In another embodiment, the proximal portion 811 has alength that is greater than the length of the distal portion 816. Thesleeve 800 includes curves, or free ends, at its proximal end and distalend. The free ends are designed to be atraumatic to body tissues. Insome embodiments, the first opening 813 has a diameter that issubstantially equal to or slightly less than a diameter of a neck of ananti-migration collar of a wire mesh structure. The sleeve 800 is slidinto the neck an anti-migration collar and then secured in place bysuturing free ends 814 at the proximal end of the sleeve to wireintersections in the neck of the anti-migration collar. The free ends818 at the distal end of the sleeve 800 circumscribe the second opening819. In various embodiments, the sleeve 800 is a short sleeve having atotal length in a range of 1 cm-120 cm. In one embodiment, the sleeve800 is a short sleeve having a total length of 10 cm. In the picturedembodiment, the conical funnel section comprises 100% of the sleevelength.

FIG. 9A is an illustration of a wire mesh structure 930 with attachedsleeve component 944 in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting a blunt end952 of a wire mesh support toward the proximal end of the sleeve 944.The sleeve 944 is connected to a proximally curving, atraumaticanti-migration collar 942 at the distal end of the wire mesh structure930 and includes a proximal section 945 having four layers and a centersection 955 having three layers.

FIG. 9B is an illustration of a wire mesh structure 957 with a proximalportion of an attached sleeve component 959 in a post deploymentconfiguration in accordance with one embodiment of the presentspecification, depicting a delivery catheter 969 positioned within thewire mesh structure 957. The sleeve 959 is attached to a proximallycurving anti-migration component 958.

FIG. 10A is an illustration of a funnel shaped braided short sleevecomponent 1000 in a post-deployment configuration, in accordance withone embodiment of the present specification. The sleeve 1000 comprises awire shape braided structure having a plurality of nodes 1001 at theproximal and distal ends of the sleeve 1000. The nodes 1001 are similarin structure to those described with reference to FIG. 3A above andcomprise unsupported free bends in the wire of the braided structure. Inone embodiment, the number of nodes is uniform such that the number ofnodes at the proximal end of the sleeve 1000 equals the number of nodesat the distal end of the sleeve 1000. In one embodiment, the number ofuniform nodes is 24 at both ends. In other embodiments, the number ofnodes is variable such that the number of nodes at the proximal end ofthe sleeve 1000 is different than the number of nodes at the distal endof the sleeve 1000. Any nodes not present at the distal end of thesleeve are staggered within the body of the sleeve. For example, in oneembodiment, the sleeve includes 24 nodes at its proximal end and 18nodes at its distal end. The remaining 6 nodes are staggered in the bodyof the sleeve. In another embodiment, the sleeve includes 24 nodes atits proximal end and 12 nodes at its distal end. The remaining 12 nodesare staggered in the body of the sleeve. Different embodiments includedifferent staggering of nodes. In one embodiment, a distal portion ofthe sleeve includes a coating 1002. In various embodiments,approximately 30-60 mm of the distal end is covered with the coating1002. In one embodiment, the coating 1002 is silicone. In oneembodiment, staggered nodes are positioned in the distal portion withthe coating 1002 and are covered to eliminate traumatic surfaces.

The sleeve 1000 depicted in FIG. 10A includes a funnel shaped portion1005 at its proximal end and a cylindrically shaped portion 1006 at itsdistal end. In one embodiment, the funnel portion 1005 includes aproximal section having a length and a distal section. In oneembodiment, the length l₁ is approximately 30 mm. The entire funnelportion has a length l₂ which, in one embodiment, is approximately 60mm. The cylindrical portion 1006 has a length l₃ which, in oneembodiment, is approximately 60 mm. Therefore, in one embodiment, thesleeve 1000 has a total length l_(t) of approximately 120 mm. The sleeve1000 has a first opening 1003 at its proximal end with a diameter d₁. Inone embodiment, the diameter d₁ is approximately 75 mm. The sleeve has asecond opening 1004 at its distal end. In various embodiments, thediameter d₂ of the second opening 1004 is 1-30 mm.

FIG. 10B is an illustration of a funnel shaped braided short sleevecomponent 1010 having a cone shaped distal end 1017 in a post-deploymentconfiguration, in accordance with one embodiment of the presentspecification. In various embodiments, the sleeve 1010 is comprised of awire braid structure having a plurality of nodes 1011 wherein saidplurality of nodes is uniform or variable as described with reference toFIG. 10A. In one embodiment, a distal portion of the sleeve includes acoating 1012. In various embodiments, approximately 30-60 mm of thedistal end is covered with the coating 1012. In one embodiment, thecoating 1012 is silicone. In one embodiment, staggered nodes arepositioned in the distal portion with the coating 1012 and are coveredto eliminate traumatic surfaces.

The sleeve 1010 depicted in FIG. 10B includes a funnel shaped portion1015 at its proximal end and a cone shaped portion 1017 at its distalend. In one embodiment, the funnel portion 1015 includes a proximalsection having a length l₁ and a distal section. In one embodiment, thelength l₁ is approximately 30 mm. The entire funnel portion has a lengthl₂ which, in one embodiment, is approximately 60 mm. The cone portion1787 has a length l₃ which, in one embodiment, is approximately 55 mm.In one embodiment, a short straight section 1016 of sleeve is positionedbetween the funnel portion 1015 and the cone portion 1017. In oneembodiment, the short straight section 1016 has a length of 5 mm.Therefore, in one embodiment, the sleeve 1010 has a total length l_(t)of approximately 120 mm. The sleeve 1010 has a first opening 1013 at itsproximal end with a diameter d₁. In one embodiment, the diameter d₁ isapproximately 75 mm. The sleeve has a second opening 1014 at its distalend with a diameter d₂. In one embodiment, the diameter d₂ isapproximately 10 mm.

FIG. 10C is an illustration of a cone shape braided short sleevecomponent 1020 in a post-deployment configuration, in accordance withone embodiment of the present specification. In various embodiments, thesleeve 1020 is comprised of a wire braid structure having a plurality ofnodes 1021 wherein said plurality of nodes is uniform or variable asdescribed with reference to FIG. 10A. In one embodiment, a distalportion of the sleeve includes a coating 1022. In various embodiments,approximately 30-60 mm of the distal end is covered with the coating1022. In one embodiment, the coating 1022 is silicone. In oneembodiment, staggered nodes are positioned in the distal portion withthe coating 1022 and are covered to eliminate traumatic surfaces. In oneembodiment, the sleeve 1020 has a total length l of approximately 120mm. The sleeve 1020 has a first opening 1023 at its proximal end with adiameter d₁. In one embodiment, the diameter d₁ is approximately 75 mm.The sleeve has a second opening 1024 at its distal end with a diameterd₂. In one embodiment, the diameter d₂ is approximately 10 mm.

FIG. 10D is an illustration of the cone shape braided short sleevecomponent 1020 of FIG. 10C attached to a wire mesh structure 1030 inaccordance with one embodiment of the present specification. Referringto FIGS. 10C and 10D simultaneously, the diameter d₁ of the firstopening 1023 of the sleeve 1020 is sized similarly to the diameter of ananti-migration collar 1034 of the wire mesh structure 1030. To attachthe wire mesh structure 1030 and sleeve 1020, the sleeve 1020 is slippedover the anti-migration collar 1034 and is attached thereto, as denotedby dashed lines 1035. Since they include first openings with similarlysized diameters, sleeve 1000 and sleeve 1010 of FIGS. 10A and 10Brespectively, are attached to a wire mesh structure is the same manneras sleeve 1020 of FIG. 10C. In other words, the sleeves 1000, 1010 areslid over an anti-migration collar of a wire mesh structure.

FIG. 10E is an illustration of a cone shape braided short sleevecomponent 1040 in a post-deployment configuration, in accordance withanother embodiment of the present specification. The sleeve 1040 issimilar to sleeve 1020 of FIG. 10C, with the exception that sleeve 1040has a smaller first opening 1043. Referring to FIG. 10E, in variousembodiments, the sleeve 1040 is comprised of a wire braid structurehaving a plurality of nodes 1041 wherein said plurality of nodes isuniform or variable as described with reference to FIG. 10A. In oneembodiment, a distal portion of the sleeve includes a coating 1042. Invarious embodiments, approximately 30-60 mm of the distal end is coveredwith the coating 1042. In one embodiment, the coating 1042 is silicone.In one embodiment, staggered nodes are positioned in the distal portionwith the coating 1042 and are covered to eliminate traumatic surfaces.In one embodiment, the sleeve 1040 has a total length l of approximately120 mm. The sleeve 1040 has a first opening 1043 at its proximal endwith a diameter d₁. In one embodiment, the diameter d₁ is approximately30 mm. The sleeve has a second opening 1044 at its distal end with adiameter d₂. In one embodiment, the diameter d₂ is approximately 10 mm.

FIG. 10F is an illustration of the cone shape braided short sleevecomponent 1040 of FIG. 10E attached to a wire mesh structure 1050 inaccordance with one embodiment of the present specification. Referringto FIGS. 10E and 10F simultaneously, the diameter d₁ of the firstopening 1043 of the sleeve 1040 is sized similarly to the diameter ofthe neck 1052 of an anti-migration collar 1054 of the wire meshstructure 1050. An outer diameter of the anti-migration collar 1054itself is greater than diameter d₁. Therefore, to attach the wire meshstructure 1050 and sleeve 1040, the sleeve 1040 is slid into theanti-migration collar 1054 and is attached to the collar neck 1052, asdenoted by dashed lines 1055.

FIGS. 10G and 10H are illustrations of cone shape braided short sleevecomponents 1060, 1065 having an atraumatic distal tip 1062, 1067 and ina post-deployment configuration, in accordance with embodiments of thepresent specification. Referring to FIGS. 10G and 10H simultaneously,the wires 1061, 1066 of the sleeve components 1060, 1065 do not extendinto the distal tips 1062, 1067. The distal tips 1062, 1067 only includethe more flexible sleeve layers, such as PTFE, and, as such, areatraumatic to the gastrointestinal mucosa. In some embodiments, thedistal tips 1062, 1067 have a diameter d₁ of approximately 10 cm and alength in a range of 5-15 cm. In some embodiments, the sleeve componentsdepicted in FIGS. 10A through 10F each include an atraumatic distal tipsimilar to those discussed with reference to FIGS. 10G and 10H.

FIG. 11A is a cross-sectional illustration depicting one embodiment ofan intragastric device 1100 with an attached sleeve 1102 in apost-deployment configuration. The device 1100 includes a wire meshstructure 1101 having a collar 1103 positioned at its distal end. Thesleeve 1102 has a cylindrically shaped body with a proximal end that isattached to the bottom surface of the collar 1103. FIG. 11B is across-sectional illustration depicting the intragastric device 1100 ofFIG. 11A in a pre-deployment configuration. As the device 1100 iscompressed into its pre-deployment configuration, the body of the sleeve1102 is pulled upon to assist in folding out the collar 1103 of the wiremesh structure 1101. The collar 1103 must be folded out so that thedevice 1100 will have a small enough diameter to fit through a deliverydevice or catheter. Referring to FIG. 11B, because the proximal end ofthe sleeve 1102 is attached to the bottom surface of the collar 1103,when the collar 1103 is folded out it creates a bulge comprising thethickness 1103′ of the collar and twice the thickness 1102′, 1102″ ofthe sleeve.

FIG. 11C is a cross-sectional illustration depicting another embodimentof an intragastric device 1110 with an attached sleeve 1112 in apost-deployment configuration. The device 1110 includes a wire meshstructure 1111 having a collar 1113 positioned at its distal end. Thesleeve 1112 has a cylindrically shaped body with a funnel shapedproximal end that is attached to the nodes or free ends at the distalend of the collar 1113. The sleeve 1112 is attached to the collar 1113via a plurality of sutures 1117. FIG. 11D is a cross-sectionalillustration depicting the intragastric device of FIG. 11C in apre-deployment configuration. As the device 1110 is compressed into itspre-deployment configuration, the body of the sleeve 1112 is pulled uponto assist in folding out the collar 1113 of the wire mesh structure1111. The sutures 1117 joining the sleeve 1112 to the collar 1113 aresecured loosely to allow for some minimal movement between the sleeve1112 and the collar 1113. Therefore, as seen in FIG. 11D, when thecollar 1113 is folded out, the funnel portion of the sleeve 1112 and thecollar 1113 move relative to one another such that the resultant bulgein the compressed device comprises only the thickness 1113′ of thecollar. This creates a lower cross-sectional area or diameter in thecompressed device and allows for easier deployment through a deliverydevice or catheter.

In addition, the collar 1113 depicted in FIG. 11C has less of a sharpbend (is more rounded) than the collar 1103 depicted in FIG. 11A. A lesssharp bend in the collar will make the collar less traumatic to bodytissues and will allow it to retain its shape since it will have a lowerstrain percentage.

FIG. 12A is an illustration of a plurality of nodes 1205 positioned atthe distal end of a wire mesh structure connected to the proximal end ofa funnel shaped sleeve 1202, in accordance with one embodiment of thepresent specification. The nodes 1205 are positioned at the distal endof the wire mesh structure or at the distal end of a collar, as seen inFIGS. 11C and 11D. Referring to FIG. 12A, each node 1205 is attached tothe sleeve 1202 by a suture 1208. As described with reference to FIGS.11C and 11D, the sutures are secured loosely to allow some movement ofthe sleeve 1202 relative to the wire mesh structure.

FIG. 12B is an illustration of a plurality of nodes 1215 positioned atthe distal end of a wire mesh structure connected to the proximal end ofa funnel shaped sleeve 1212, in accordance with another embodiment ofthe present specification. As depicted in FIG. 12B, only every othernode 1215 is attached to the sleeve via a suture 1218. While stillfixedly attaching the wire mesh structure to the sleeve 1212, thereduction in the number of sutures 1218, when compared with theembodiment shown in FIG. 12A, creates a device in the compressedpre-deployment configuration having a bulge with a smaller diameter.Such a compressed device will pass more easily through a delivery deviceor catheter.

Securing the sutures directly to the most distal end of the nodes canresult in too much movement of the sleeve relative to the wire meshstructure as the sutures slide along the wires of each node. FIG. 12C isan illustration of a plurality of nodes 1225 positioned at the distalend of a wire mesh structure connected to the proximal end of a funnelshaped sleeve 1222, in accordance with another embodiment of the presentspecification. Rather than placing the suture on the most distal end ofeach node 1225, the sutures 1228 are placed about the intersections 1229of the wires of two adjacent nodes 1225. This prevents sliding of thesutures too far along any one wire while still allowing for the minimummovement of the sleeve 1222 relative to the wire mesh structure duringcompression.

FIG. 12D is an illustration of a plurality of nodes 1235 positioned atthe distal end of a wire mesh structure connected to the proximal end ofa funnel shaped sleeve 1232, in accordance with another embodiment ofthe present specification. As depicted in FIG. 12D, only every otherintersection 1239 of wires of adjacent nodes 1235 is attached to thesleeve via a suture 1238. While still fixedly attaching the wire meshstructure to the sleeve 1232, the reduction in the number of sutures1238, when compared with the embodiment shown in FIG. 12C, creates adevice in the compressed pre-deployment configuration having a bulgewith a smaller diameter. Such a compressed device will pass more easilythrough a delivery device or catheter.

FIG. 12E is an illustration of a plurality of nodes 1245 positioned atthe distal end of a wire mesh structure connected to the proximal end ofa funnel shaped sleeve 1242, in accordance with another embodiment ofthe present specification. The nodes 1245 are positioned at the distalend of the wire mesh structure or at the distal end of an anti-migrationcollar and include loops 1246 formed from the wire of the nodes 1245 andextending in a direction toward the center of the wire mesh structure.Each loop 1246 of each node 1205 is attached to the sleeve 1242 by asuture 1248.

FIG. 12F is an illustration of a plurality of nodes 1255 positioned atthe distal end of a wire mesh structure connected to the proximal end ofa funnel shaped sleeve 1252, in accordance with yet another embodimentof the present specification. The nodes 1255 are positioned at thedistal end of the wire mesh structure or at the distal end of ananti-migration collar and include loops 1256 formed from the wire of thenodes 1255 and extending in a direction toward the center of the wiremesh structure. Each loop 1256 of each node 1255 is attached to thesleeve 1252 by a suture 1258. As depicted in FIG. 12F, only every othernode 1255 is attached to the sleeve via a suture 1258. While stillfixedly attaching the wire mesh structure to the sleeve 1252, thereduction in the number of sutures 1258, when compared with theembodiment shown in FIG. 12E, creates a device in the compressedpre-deployment configuration having a bulge with a smaller diameter.Such a compressed device will pass more easily through a delivery deviceor catheter.

FIG. 13A is an illustration of a plurality of nodes 1305 positioned atthe distal end of a wire mesh structure connected to the proximal end ofa funnel shaped sleeve 1302, in accordance with an embodiment of thepresent specification. As depicted in FIG. 13A, both the intersections1309 between some adjacent nodes 1305 and the ends 1304 of some nodes1305 are sutured to the sleeve 1302 with knots 1308.

In one embodiment, the distal end of a wire mesh structure is connectedto the proximal end of a sleeve at 9 standalone connection points. Eachconnection point comprises a FIG. eight knot additionally secured withglue and a heat shrink tube. In one embodiment, each knot comprises 30lb. break-strength ultra-high-molecular-weight-polyethylene (UHMWPE)braided suture line to provide a reliable connection between wire meshand sleeve. FIG. 13B is an illustration of a distal end of a wire meshstructure 1320 and connected proximal end of a funnel shaped sleevecovered with a heat shrink tube 1326, in accordance with one embodimentof the present specification.

FIG. 14 is an illustration of an intragastric device 1400 with a funnelshaped sleeve 1410 in a post-deployment configuration, in accordancewith one embodiment of the present specification. The intragastricdevice 1400 includes a wire mesh structure 1405 having a proximal endand a distal end with an anti-migration collar 1420 formed at saiddistal end. The sleeve 1410 includes a proximal end and a distal end andis attached via its proximal end to the anti-migration collar 1420.

The wire mesh structure 1405 comprises at least one metal wire foldedabout itself to create a crisscross weave pattern with a plurality offree curved ends, or nodes, along the structure. In its expanded,post-deployment configuration, the wire mesh structure 1405 has an ovalshape. To facilitate optimal expansion and compression for easierdelivery and removal, the wire mesh structure 1405 includes a pluralityof staggered nodes 1406, 1407, 1408, 1409 along its length. A first setof staggered nodes 1406 is positioned at the proximal end of the wiremesh structure 1405 and circumscribes a first opening 1401. In oneembodiment, each node in said first set of staggered nodes 1406 is bentupwards to extend in a direction opposite from an interior of the wiremesh structure 1405. The nodes in said first set of staggered nodes 1406are used as grasping points fora retrieval device during removal of theintragastric device 1400. The wire mesh structure 1405 includes a secondset of staggered nodes 1407 distal to said first set 1406 and proximalto a midpoint of said wire mesh structure 1405. A third set of staggerednodes 1408 is positioned distal to said midpoint and proximal to thedistal end of the wire mesh structure 1405. A fourth set of staggerednodes 1409 is positioned at the distal end of the wire mesh structure1405 and comprises the free end of the anti-migration component 1420.All of the curves comprising the nodes in each set of staggered nodes1406, 1407, 1408, 1409 are designed to have a bend that is atraumatic tobody tissues. The nodes are staggered to prevent bunching of the bendingpoints of the wire and bulking of the wire mesh structure as it iscompressed to its pre-deployment configuration. Spreading the nodesalong the length of the wire mesh structure allows for an overallsmaller diameter of the device once it is compressed.

The sleeve 1410 includes a proximal portion 1411 and a distal portion1416 which join at a transition point 1415 along the sleeve 1410 body.Both the proximal portion 1411 and the distal portion 1416 of the sleeve1410 are funnel shaped, each having a diameter that decreases as theportions 1411, 1416 extend distally. In one embodiment, the diameter ofthe proximal portion 1411 is substantially the same as the diameter ofthe anti-migration collar 1420 at a proximal end of said proximalportion 1411. The diameter of the proximal portion 1411 decreases as theproximal portion 1411 extends distally until the sleeve 1410 transitionsinto its distal portion 1416, at which point the diameters of theproximal portion 1411 and the distal portion 1416 are equal. Thediameter of the distal portion 1416 then decreases as said distalportion 1416 extends distally. The distal portion 1416 of the sleeve1410 ends in a second opening 1419 at a distal end of the intragastricdevice 1400. In one embodiment, the proximal portion 1411 has a lengththat is less than a length of the distal portion 1416. In variousembodiments, the funnel shaped sleeve 1410 comprises at least one wiresupport. In some embodiments, the at least one wire support comprisesthe same wire(s) in both the proximal portion 1411 and distal portion1416. In other embodiments, the proximal portion 1411 and distal portion1416 comprise separate wire supports and the wires are joined togetherat a distal end of the proximal portion 1411 and a proximal end of thedistal portion 1416. In one embodiment, the separate wires are spotwelded together. The wire is folded upon itself to create a crisscrossweave pattern in the sleeve 1410. In both the proximal 1411 and distalportions 1416, the intersecting sections of the wire come closer to oneanother as the portions 1411, 1416 extend distally and the funnel shapenarrows, such that the weave pattern becomes tighter at the distal endsof each portion 1411, 1416. The sleeve 1410 includes curves or freeends, similar to the nodes of the wire mesh structure 1405, at itsproximal end and distal end. The free ends are designed to be atraumaticto body tissues. The free ends at the proximal end of the sleeve 1410are attached to the nodes of the fourth set of staggered nodes 1409 ofthe wire mesh structure 1405 via one or more sutures 1422. The free endsat the distal end of the sleeve 1410 circumscribe the second opening1419. In various embodiments, the sleeve 1410 is a short sleeve having atotal length in a range of 5 cm-120 cm. In one embodiment, the sleeve1410 is a short sleeve having a total length of 60 cm. In oneembodiment, the sleeve 1410 includes a soft atraumatic tip 1430 at itsdistal end. The tip 1430 contains no wires and is included to preventinjury to the intestinal mucosa from the sleeve tip.

When the sleeve 1410 is attached to the wire mesh structure 1405, theproximal end of the proximal portion 1411 of the sleeve 1410 is slidover and covers at least a portion of the anti-migration component 1420such that the proximal portion 1411 of the sleeve 1410 covers an openingat the distal end of the wire mesh structure. This positioning enablesfluid communication between the interior of the wire mesh structure 1405and an interior of the sleeve 1410 and establishes a pathway for foodfrom said first opening 1401, into said interior of said wire meshstructure 1405, through said interior of said sleeve 1410, and out ofsaid second opening 1419.

FIG. 15 is an illustration of an intragastric device 1500 with acylindrically shaped sleeve 1510 in a post-deployment configuration, inaccordance with one embodiment of the present specification. Theintragastric device 1500 includes a wire mesh structure 1505 having aproximal end and a distal end with an anti-migration collar 1520 formedat said distal end. The sleeve 1510 includes a proximal end and a distalend and is attached via its proximal end to the anti-migration collar1520. In one embodiment, the sleeve 1510 includes a soft atraumatic tip1530 at its distal end. The tip 1530 contains no wires and is includedto prevent injury to the intestinal mucosa from the sleeve tip.

The wire mesh structure 1505 is similar to the structure 1405 discussedwith reference to FIG. 14 and includes an oval shape with a crisscrossweave pattern, a plurality of staggered nodes 1506, 1507, 1508, 1509,and a first opening 1501 at its proximal end. All of the curvescomprising the nodes in each set of staggered nodes 1506, 1507, 1508,1509 are designed to have a bend that is atraumatic to body tissues.

The sleeve 1510 includes a proximal portion 1511 and a distal portion1516 which join at a transition point 1515 along the sleeve 1510 body.The proximal portion 1511 of the sleeve 1510 is funnel shaped andincludes a diameter that decreases as the portion 1511 extends distally.In one embodiment, the diameter of the proximal portion 1511 issubstantially the same as the diameter of the anti-migration collar 1520at a proximal end of said proximal portion 1511. The diameter of theproximal portion 1511 decreases as the proximal portion 1511 extendsdistally until the sleeve 1510 transitions into its distal portion 1516,at which point the diameters of the proximal portion 1511 and the distalportion 1516 are equal. The diameter of the distal portion 1516 thencontinues at the same size as said distal portion 1516 extends distally,giving the distal portion 1516 a substantially cylindrical shape. Thedistal portion 1516 of the sleeve 1510 ends in a second opening 1519 ata distal end of the intragastric device 1500. In one embodiment, theproximal portion 1511 has a length that is less than a length of thedistal portion 1516.

In various embodiments, the funnel shaped proximal portion 1511 of thesleeve 1510 comprises at least one wire support. The wire is folded uponitself to create a crisscross weave pattern in the sleeve 1510. Theintersecting sections of the wire come closer to one another as theportion 1511 extends distally and the funnel shape narrows, such thatthe weave pattern becomes tighter at the distal end of the proximalportion 1511. In various embodiments, the distal portion 1516 includesat least one helical wire support extending along its cylindricallength. The helical wire support has a consistent pitch such that aresultant helical weave structure has the same pattern along the lengthof the distal portion 1516 of the sleeve 1510. In some embodiments, thehelical wire support of the distal portion 1516 is an extension of theat least one wire support of the proximal portion 1511. In otherembodiments, the proximal portion 1511 and distal portion 1516 compriseseparate wire supports and the wires are joined together at a distal endof the proximal portion 1511 and a proximal end of the distal portion1516. In one embodiment, the separate wires are spot welded together.The sleeve 1510 includes curves or free ends, similar to the nodes ofthe wire mesh structure 1505, at its proximal end and distal end. Thefree ends are designed to be atraumatic to body tissues. The free endsat the proximal end of the sleeve 1510 are attached to the nodes of thefourth set of staggered nodes 1509 of the wire mesh structure 1505 viaone or more sutures 1522. The free ends at the distal end of the sleeve1510 circumscribe the second opening 1519. In various embodiments, thesleeve 1510 is a short sleeve having a total length in a range of 5cm-120 cm. In one embodiment, the sleeve 1510 is a short sleeve having atotal length of 60 cm. The funnel shaped conical section can vary frombeing 1% of the total sleeve length to being 100% of the total sleevelength.

When the sleeve 1510 is attached to the wire mesh structure 1505, theproximal end of the proximal portion 1511 of the sleeve 1510 is slidover the anti-migration component 1520 such that the proximal portion1511 of the sleeve 1510 covers an opening at the distal end of the wiremesh structure. This positioning enables fluid communication between theinterior of the wire mesh structure 1505 and an interior of the sleeve1510 and establishes a pathway for food from said first opening 1501,into said interior of said wire mesh structure 1505, through saidinterior of said sleeve 1510, and out of said second opening 1519.

FIG. 16A is a close-up illustration of a funnel shaped sleeve 1602attached to an anti-migration collar 1604 of a wire mesh structure 1605of an intragastric device 1600, in accordance with one embodiment of thepresent specification. The sleeve 1602 is attached to the anti-migrationcollar 1604 via a plurality of sutures 1608.

FIG. 16B is a close-up illustration of a funnel shaped sleeve 1612attached to an anti-migration collar 1614 of a wire mesh structure 1615of an intragastric device 1610, in accordance with another embodiment ofthe present specification. The sleeve 1612, attached to theanti-migration collar 1614 via a plurality of sutures 1618, includes aplurality of frayed edges 1611 at its proximal end to make said edgesless traumatic to body tissues.

FIG. 16C is an illustration of an intragastric device 1620 comprising awire mesh structure 1625 and attached sleeve 1622, in accordance withone embodiment of the present specification. The wire mesh structure1625 is anchorless and includes atraumatic wire ends. In one embodiment,the wire mesh structure 1625 is composed of Nitinol. The wire meshstructure 1625 includes an anti-migration collar 1624 to which thesleeve 1622 is attached. In some embodiments, the wire mesh structure1625 includes retrieval drawstrings positioned proximate its proximalend, as depicted with reference to FIG. 16E. The sleeve 1622 comprisesan anchorless, impermeable, fluoropolymer liner designed to extend intothe proximal portion of the small bowel, particularly the mid-duodenum.In various embodiments, the sleeve 1622 includes an embedded Nitinolstent structure within polymer layers such that the sleeve 1622 isatraumatic and no portion of the Nitinol comes into contact with thesmall intestine. In one embodiment, the sleeve 1622 includes radiopaquemarkers for assistance with proper delivery and placement.

The wire mesh structure 1625 is anchorless and occupies a space withinthe stomach. The wire mesh structure 1625 is free to float within thestomach and intermittently exerts gentle, atraumatic stretching forceson a portion of the stomach as it comes into contact with the innerstomach wall. The stretching forces induce the sensation of satiety inthe patient. The anti-migration collar 1624 is appropriately shaped toreceive the attached sleeve 1622. Gastric contents enter the wire meshstructure 1625 through a first opening 1621 at the proximal end of thewire mesh structure 1625 or through openings 1629 between the wires ofthe wire mesh structure 1625 and are directed into the attached sleeve1622. The gastric contents then pass through the sleeve 1622 and emptyout a second opening 1623 at the distal end of the sleeve 1622, eitherinto the duodenum or jejunum, depending on the length of the sleeve1622. The sleeve 1622 is pre-attached to the anti-migration collar 1624of the wire mesh structure 1625. The Nitinol stent structure embedded inthe sleeve 1622 provides support to the sleeve 1622 and prevents it fromtorsion or being kinked by actions of the intestinal musculature.Additionally, the Nitinol stent structure provides a gentle, radialstretching force on the small intestinal wall, inducing a sensation ofsatiety in the patient and preventing the passage of chyme around thesleeve 1622.

FIG. 16D is an illustration of the intragastric device 1620 of FIG. 16Cwith the sleeve 1622 straightened to depict the device 1620 dimensionsrelative to the surrounding anatomy. The sleeve 1622 includes aproximal, funnel or cone shaped portion 1622 p attached to theanti-migration collar of the wire mesh structure 1625 and a distal,cylindrically shaped portion 1622 d extending distally from saidproximal portion 1622 p. The wire mesh structure 1625 and proximalportion 1622 p of the sleeve 1622 are configured to reside in thestomach of the patient and together have a maximum outer diameter ofapproximately 8 inches and a length l₁. In some embodiments, length isapproximately 10 inches. In some embodiments, the volume of a fullydeployed wire mesh structure 1625 is approximately 1 liter. The proximalportion 1622 p of the sleeve 1622 and the distal portion 1622 d of thesleeve 1620 meet at a junction point 1622 j which is configured to sitat the patient's pylorus. The distal portion 1622 d of the sleeve 1620is configured to reside in the small intestine of the patient,particularly the duodenum, and has a maximum outer diameter ofapproximately 1.0 inches and a length l₂. In some embodiments, length l₂is approximately 10 to 25 inches. In some embodiments, the length l₂ ofthe distal portion 1622 d is such that the distal end of the sleeve 1622is positioned in the duodenum so gastric contents pass from the stomach,through the device 1620, and directly into the duodenum, bypassing thepylorus. In other embodiments, the length l₂ is such that the distal endof the sleeve 1622 is positioned in the jejunum so gastric contents passfrom the stomach, through the device 1620, and directly into thejejunum, bypassing the pylorus and duodenum. In other embodiments, thewire mesh structure has a maximum diameter of 18 inches, a maximumlength of 24 inches, and a maximum volume of 2.5 liters.

FIG. 16E is an illustration of a wire mesh structure 1635 and sleeve1632 of an intragastric device 1630, depicting retrieval drawstrings1637, 1638 on said wire mesh structure 1635, in accordance with oneembodiment of the present specification. The sleeve 1632 is attached toan anti-migration collar 1634 at the distal end of the wire meshstructure 1635. In some embodiments, the anti-migration collar 1634includes loops in the wires of the nodes at the distal end of the nodes,as seen with reference to FIG. 4C, and the sleeve 1632 is sutured to theanti-migration collar 1634 at these loops. In the pictured embodiment, apair of retrieval drawstrings 1637, 1638 are located on the wire meshstructure 1635 proximate its proximal end. A first drawstring 1637 ispositioned at the proximal end of the wire mesh structure 1635 and thesecond drawstring 1638 is positioned distal to the first drawstring 1637but still proximate the proximal end of the wire mesh structure 1635.The retrieval drawstrings 1637, 1638 pass through the openings betweenthe wires of the wire mesh structure 1635. During retrieval, free endsof the retrieval drawstrings 1637, 1638 are pulled on using a grasper toconstrict the wire mesh structure 1635 to a smaller outer diameter so itmay be removed from the patient through an endoscope. In one embodiment,the two drawstrings 1637, 1638 are interconnected operably such thatconstricting one drawstring results in the other drawstring constrictingsimultaneously.

FIG. 16F is an illustration of a wire mesh structure 1645 and sleeve1642 of an intragastric device 1640, depicting a single retrievaldrawstring 1648 on said wire mesh structure 1645, in accordance with oneembodiment of the present specification. The sleeve 1642 is attached toan anti-migration collar 1644 at the distal end of the wire meshstructure 1645. In some embodiments, the anti-migration collar 1644includes loops in the wires of the nodes at the distal end of the nodes,as seen with reference to FIG. 4C, and the sleeve 1642 is sutured to theanti-migration collar 1644 at these loops. In the pictured embodiment, asingle retrieval drawstring 1648 is located on the wire mesh structure1645 proximate its proximal end. The retrieval drawstrings 1648 passesthrough the openings between the wires of the wire mesh structure 1645.During retrieval, free ends of the retrieval drawstring 1648 are pulledon using a grasper to constrict the wire mesh structure 1645 to asmaller outer diameter so it may be removed from the patient through anendoscope. In the pictured embodiment, the single drawstring 1648 issufficient to constrict two pluralities of nodes 1647, 1649 on the wiremesh structure 1645, a first plurality 1647 at the proximal end of thewire mesh structure 1645 and a second plurality 1649 at the level of thedrawstring 1648. In other embodiments, a single drawstring is sufficientfor constricting one or more than two pluralities of nodes on the wiremesh structure.

In some embodiments, wherein the sleeve includes metal wire supports,the ends of the wire or wires are designed to be atraumatic to bodytissues. In various embodiments, the wire ends are blunted, folded uponthe wire, or welded to other wire ends. In other embodiments, the distalend of the sleeve includes a component designed to make said distal endatraumatic to body tissues. FIG. 17A is a cross-sectional illustrationof a distal end of a sleeve 1705, depicting one embodiment of acomponent 1710 designed to configure said distal end to be atraumatic tobody tissues. The component 1710 has a cylindrical shape with a proximalend 1711, a distal end 1719, and a lumen 1716 within. The component 1710is open at both ends 1711, 1719. The lumen 1716 of the component 1710 isin fluid communication with a lumen 1706 of the sleeve 1705 to allow forfood to pass through the wire mesh of the device, the sleeve 1705, andthe component 1710. The distal end 1719 is rounded into a blunt shapethat is atraumatic to body tissues. An outer surface of the component1710 includes a groove 1713 configured to receive a circular member orO-ring 1714. To attach the component 1710 to the sleeve 1705, the distalend of the sleeve 1705 is coaxially slid onto the proximal end 1711 ofthe component 1710 such that a portion of the sleeve 1705 is positionedover said groove 1713. The O-ring 1714 is then placed over the sleeve1705 and into the groove 1713, providing a robust connection of thesleeve 1705 to the component 1710. The distal sleeve end 1707 is thenfolded in a proximal direction back toward the sleeve 1705 body. In oneembodiment, the component 1710 includes a circular flange 1712 whichextends outwardly from the outer surface of the component 1710 and thenin a proximal direction. The flange 1712 serves to cover any sharp endspresent in the folded distal sleeve end 1707 and further protect bodytissues from trauma. In various embodiments, the component 1710 has alength in a range of 5 mm to 500 mm, an outside diameter in a range of 3mm to 30 mm, and an inside diameter in a range of 0.5 to 50 mm.

FIG. 17B is a cross-sectional illustration of a distal end of a sleeve1705, depicting another embodiment of a component 1720 designed toconfigure said distal end to be atraumatic to body tissues. Thecomponent 1720 has a cylindrical shape with a proximal end 1721, adistal end 1729, and a lumen 1726 within. The component 1720 is open atboth ends 1721, 1729. The lumen 1726 of the component 1720 is in fluidcommunication with a lumen 1706 of the sleeve 1705 to allow for food topass through the wire mesh of the device, the sleeve 1705, and thecomponent 1720. The distal end 1729 is rounded into a blunt shape thatis atraumatic to body tissues. An outer surface of the component 1720includes a groove 1723 configured to receive a circular member or O-ring1724. To attach the component 1720 to the sleeve 1705, the distal end ofthe sleeve 1705 is coaxially slid onto the proximal end 1721 of thecomponent 1720 such that a portion of the sleeve 1705 is positioned oversaid groove 1723. The O-ring 1724 is placed over the sleeve 1705 andinto the groove 1723. The distal sleeve end is then folded in a proximaldirection back toward the sleeve 1705 body. A heat shrink tube 1725 isthen placed over said distal sleeve end and said O-ring 1724. Heat isapplied to the heat shrink tube 1725 to shrink the tube 1725 such thatit securely connects the sleeve 1705 to the component 1720. Any sharpends in the distal sleeve end are contained under the heat shrink tube1725 and are not exposed to body tissues.

FIG. 17C is a cross-sectional illustration of a distal end of a sleeve1705, depicting another embodiment of a component 1730 designed toconfigure said distal end to be atraumatic to body tissues. Thecomponent 1730 has a cylindrical shape with a proximal end 1731, adistal end 1739, and a lumen 1736 within. The component 1730 is open atboth ends 1731, 1739. The lumen 1736 of the component 1730 is in fluidcommunication with a lumen 1706 of the sleeve 1705 to allow for food topass through the wire mesh of the device, the sleeve 1705, and thecomponent 1730. The distal end 1739 is rounded into a blunt shape thatis atraumatic to body tissues. An outer surface of the component 1730includes a groove 1733 configured to receive a circular member or O-ring1734. To attach the component 1730 to the sleeve 1705, the sleeve 1705is first everted to be inside out. The distal end of the sleeve 1705 isthen coaxially slid onto the distal end 1739 of the component 1730 suchthat a portion of the sleeve 1705 is positioned over said groove 1733.The O-ring 1734 is placed over the sleeve 1705 and into the groove 1733.The sleeve 1705 is then folded in a proximal direction back over theO-ring 1734 and proximal end 1731 of the component 1730, providing arobust connection of the sleeve 1705 to the component 1730. This processof connecting the sleeve 1705 to the component 1730 ensures that thedistal sleeve end 1707 will become positioned within the sleeve lumen1706. Any sharp ends in the distal sleeve end 1707 are contained withinthe sleeve lumen 1706 and are not exposed to body tissues.

FIG. 18 is an illustration of a distal end of a sleeve 1805 with apositioning tail 1810 attached thereto, in accordance with oneembodiment of the present specification. The positioning tail 1810 isattached to the distal end of a short sleeve 1805 having a length of 5mm to 500 mm. The positioning tail 1810 comprises a ribbon of materialextending from the distal end of the sleeve 1805 into a patient'sduodenum and is used to help maintain proper implant orientation of thesleeve 1805 relative to a patient's pylorus. In various embodiments, thepositioning tail 1810 has a length l in a range of 5 mm to 500 mm. Inone embodiment, the positioning tail 1810 has a length l of 25 mm. Inone embodiment, the distal end of the positioning tail 1810 includes abead 1815 for weighing down said distal end. In another embodiment, thedistal end of the positioning tail includes a plurality of separate freeends similar to a horse tail. In other embodiments, the distal end ofthe positioning tail includes any mechanism or component designed toprovide additional weight or tugging upon said distal end to allow forpulling on said tail to ensure proper sleeve orientation. In oneembodiment, the distal end of the positioning tail does not include anyadditional components.

FIG. 19A is an illustration of a distal end of a sleeve 1905 comprisinga plurality of fringes 1907 joined to a ring 1908, in accordance withone embodiment of the present specification. In various embodiments, thedistal end of the sleeve 1905 comprises two or more fringes 1907. In oneembodiment, the distal end of the sleeve 1905 comprises four fringes1907. Each fringe 1907 comprises a portion of sleeve material which isseparate from adjacent fringes 1907. The fringes 1907 are separated fromone another by a space 1906 which allows food passing through theintragastric device to exit from the sleeve 1905. In variousembodiments, each fringe 1907 has a length in a range of 5 mm to 500 mmand a width in a range of 1 mm to 15 mm. In some embodiments, the widthof each fringe 1907 decreases as the fringe 1907 extends distally. Thefringes 1907 are connected to a ring 1908 at the most distal end of thesleeve 1905. The ring 1908 includes a center opening 1909 for passage offood. In some embodiments, the ring 1908 is semi-rigid. In variousembodiments, the ring 1908 has an outer diameter in a range of 1 mm to30 mm and an inner diameter in a range of 1 mm to 30 mm. In variousembodiments, the ring 1908 is attached to each fringe 1907 via suturing,gluing, bonding or any other method of attachment. The ring 1908 servesto join the fringes 1907 together and to weigh down the distal end ofthe sleeve 1905 to assist with proper device orientation. The surfacesof the ring 1908 are blunted to be atraumatic to body tissues. In someembodiments, the fringes 1907 and ring 1908 are parachute shaped.

FIG. 19B is an illustration of a distal end of a sleeve 1910 comprisinga plurality of fringes 1912 joined to a ball 1913, in accordance withone embodiment of the present specification. In various embodiments, thedistal end of the sleeve 1910 comprises two or more fringes 1912. In oneembodiment, the distal end of the sleeve 1910 comprises four fringes1912. Each fringe 1912 comprises a portion of sleeve material which isseparate from adjacent fringes 1912. The fringes 1912 are separated fromone another by a space 1911 which allows food passing through theintragastric device to exit from the sleeve 1910. In variousembodiments, each fringe 1912 has a length in a range of 5 mm to 500 mmand a width in a range of 1 mm to 15 mm. In some embodiments, the widthof each fringe 1912 decreases as the fringe 1912 extends distally. Thefringes 1912 are connected to a ball 1913 at the most distal end of thesleeve 1910. In various embodiments, the ball 1913 has a diameter in arange of 2 mm to 30 mm. In various embodiments, the ball 1913 is gluedor bonded to each fringe 1907. The ball 1913 serves to join the fringes1912 together and to weigh down the distal end of the sleeve 1910 toassist with proper device orientation. Since the ball 1913 has aspherical shape, it has no sharp edges and is atraumatic to bodytissues. In another embodiment, the most distal ends of the fringes 1912are tied together into a knot to form the ball 1913 and no additionalball component is required. In some embodiments, the fringes 1912 andball 1913 are parachute shaped.

In one embodiment, as seen in FIG. 19C, the ball 1913 includes a lumen1933 to allow for passage of a guide wire. In another embodiment, theball 1913 has a groove or depression 1932 to receive an inner pushercatheter or plunger of a delivery device. In one embodiment, thecircumference of the ball is designed to sit inside an outer catheter ofa delivery device.

FIG. 19D is an illustration of a distal end of a sleeve 1915 having aplurality of sutures 1917 extending therefrom and joined to a ball 1918,in accordance with one embodiment of the present specification. Invarious embodiments, the sleeve 1915 includes two or more sutures 1917.In one embodiment, the sleeve 1915 includes six sutures 1917. In variousembodiments, the sutures 1917 have a length in a range of 5 mm to 500mm. In one embodiment, the sutures 1917 are composed of nylon. Aproximal end of each suture 1917 is attached to the distal end of thesleeve 1915 and a distal end of each suture 1917 is attached to a ball1918. In various embodiments, the ball 1918 is glued to each suture1917. In various embodiments, the ball has a diameter in a range of 3 mmto 30 mm. The ball 1918 is designed to add weight to the distal end ofthe sleeve 1915 to pull the sleeve 1915 into the proper implantorientation. Since the ball 1918 has a spherical shape, it has no sharpedges and is atraumatic to body tissues. Food exits the distal end ofthe sleeve 1915 and passes through the spaces 1916 between the sutures1917. In one embodiment, the ball 1918 includes a center opening 1919for the passage of guidewire there through. In various embodiments, theball 1918 is replaced by a ring or similarly designed component to weighdown the sleeve 1915 and ensure proper device orientation. In someembodiments, the sutures 1917 and ball 1918 are parachute shaped.

FIG. 19E is an illustration of a distal end of a sleeve 1920 having atleast one suture 1922 with attached suture loop or bead 1923 extendingtherefrom, in accordance with one embodiment of the presentspecification. In one embodiment, the sleeve 1920 includes six sutures1922. In various embodiments, the sutures 1922 have a length in a rangeof 5 mm to 500 mm. In one embodiment, the sutures 1922 are composed ofUHMWPE. A proximal end of each suture 1922 is attached to the distal endof the sleeve 1920 and a distal end of each suture 1922 includes anattached suture loop or bead 1923. The suture loops or beads 1923 aredesigned to add weight to the distal end of the sleeve 1920 to pull thesleeve 1920 into the proper implant orientation. Since the suture loopsor beads 1923 each have a spherical shape, they have no sharp edges andare atraumatic to body tissues.

FIG. 20A is an illustration of a distal end of a sleeve 2005 depictingat least one fold 2007 in the sleeve wall 2006, in accordance with oneembodiment of the present specification. In one embodiment, the sleeve2005 includes three folds 2007 in its wall 2006. The folds 2007 arecreated along a longitudinal axis of the sleeve 2005. In variousembodiments, the folds 2007 are positioned equidistant from one another.Referring to FIG. 20A, the sleeve 2005 is folded over itself twiceresulting in three layers of sleeve wall 2006 at each fold 2007. Thesleeve layers are bonded to each other at each fold 2007. In oneembodiment, the sleeve layers are thermally fused together. The foldingof the sleeve wall 2006 produces a pleated effect which adds structureand stability to the sleeve 2005. The added structure helps maintain thesleeve 2005 in the proper orientation relative to a patient's pylorusand assists in preventing deformation of the sleeve 2005 by actions ofthe patient's gastrointestinal tract.

FIG. 20B is an illustration of a distal end of a sleeve 2010 depictingat least one channel 2012 and support structure 2013 within the sleevewall 2011, in accordance with one embodiment of the presentspecification. In one embodiment, the sleeve 2010 includes four channels2012 in its wall 2011 and each channel 2012 includes a support structure2013 within. In various embodiments, the support structures 2013comprise tubes or beads. In various embodiments, the support structures2013 are sized to fit snugly within the channels 2012. The channels 2012extend along a longitudinal axis of the sleeve 2010. In one embodiment,the channels 2012 extend the entire length of the sleeve 2010. In otherembodiments, the channels extend only along a portion of the distal endof the sleeve 2010. In various embodiments, the channels 2012 arepositioned equidistant from one another. The inclusion of the channels2012 and support structures 2013 adds structure and stability to thesleeve 2010. The added structure helps maintain the sleeve 2010 in theproper orientation relative to a patient's pylorus and assists inpreventing deformation of the sleeve 2010 by actions of the patient'sgastrointestinal tract. In one embodiment, the channel 2012 is a hollowchannel which can be filled or inflated with a fluid, such as water orair, to provide rigidity and/or structure to the sleeve 2010.

FIG. 20C is an illustration of a portion of a sleeve 2015 depicting acorrugated sleeve wall in accordance with one embodiment of the presentspecification. The sleeve 2015 includes a plurality of alternatingannular grooves 2016 and ridges 2017 extending along its length. In oneembodiment, the entire sleeve 2015 is corrugated. In other embodiments,only a portion of the distal end of the sleeve 2015 is corrugated. Invarious embodiments, the corrugated portion of the sleeve 2015 iscomposed of fluoropolymer or polyethylene (PE). Referring to FIG. 20C,in one embodiment, the corrugated portion of the sleeve 2015 iscylindrical and includes a consistent diameter along its entire length.In another embodiment, the corrugated portion of the sleeve is funnelshaped and includes a diameter that decreases as the sleeve extendsdistally. In various embodiments, the distal end of the corrugatedsleeve 2015 is configured to be soft, rounded, and atraumatic to bodytissues. The corrugated structure helps maintain the sleeve 2015 in theproper orientation relative to a patient's pylorus and assists inpreventing deformation of the sleeve 2015 by actions of the patient'sgastrointestinal tract.

FIG. 20D is an illustration of portion of a sleeve 2020 depicting aknitted sleeve wall in accordance with one embodiment of the presentspecification. The sleeve 2020 includes a knitted wire pattern 2021extending along its length. In one embodiment, the entire sleeve 2020 isknitted. In other embodiments, only specific portions, such as thedistal end, of the sleeve 2020 are knitted. Referring to FIG. 20D, inone embodiment, the knitted portion of the sleeve 2020 is cylindricaland includes a consistent diameter along its entire length. In variousembodiments, the diameter of the sleeve 2020 ranges from 1 cm-10 cm. Inone embodiment, the diameter of the sleeve is 25 mm and the length is500 mm. In another embodiment, the knitted portion of the sleeve isfunnel shaped and includes a diameter that decreases as the sleeveextends distally. In various embodiments, the distal end of the knittedsleeve 2020 is configured to be soft, rounded, and atraumatic to bodytissues. The knitted structure helps maintain the sleeve 2020 in theproper orientation relative to a patient's pylorus and assists inpreventing deformation of the sleeve 2020 by actions of the patient'sgastrointestinal tract. The knitted structure provides the sleeve 2020with structural integrity and prevents the sleeve 2020 from becomingkinked, twisted, or obstructed. In various embodiments, the sleeve 2020has a radial force high enough to prevent deformation by the peristalticactions of the gastrointestinal tract but low enough such that thesleeve 2020 can be compressed to allow food to propagate through thesleeve 2020. In addition, the radial force is low enough such that thesleeve is not too rigid which can result in trauma to thegastrointestinal tract, including abrasions. In one embodiment, theknitted structure of the sleeve 2020 functions similarly to a stent,keeping the sleeve 2020 properly positioned within the patient's smallintestine.

FIG. 20E is an illustration of portion of a sleeve 2025 depicting aknitted sleeve wall and a distal sleeve end having frayed edges 2028, inaccordance with one embodiment of the present specification. The sleeve2025 includes a knitted wire pattern 2026 extending along its length.The frayed edges 2028 at the distal end of the sleeve 2025 are lesstraumatic to body tissues.

FIGS. 20F to 20L are illustrations of exemplary sleeve knit patterns2031, 2032, 2033, 2034, 2035, 2036, 2037 in accordance with variousembodiments.

FIG. 21A is an illustration of an intragastric device 2130 having anoval shaped wire mesh structure 2131 deployed in the gastrointestinaltract of a patient, in accordance with one embodiment of the presentspecification. In the pictured embodiment, the device 2130 includes awire mesh structure 2131 having an anti-migration collar 2134 andattached sleeve 2132. The device 2130 is deployed such that the wiremesh structure 2131 resides in the stomach 2160 with the anti-migrationcollar 2134 positioned just proximal to the pylorus 2161 and the sleeve2132 extending through the pylorus 2161 and into the duodenum 2170. Thedistal end of the sleeve 2132 resides in the duodenum 2170. Theanti-migration collar prevents migration of the totality of the device2130 through the pylorus 2161 and into the duodenum 2170. The device2130 occupies a volume of the stomach 2160, does not move entirely pastthe pylorus 2161, and provides a bypass for food past the pylorus 2161and a portion of the duodenum 2170. In various embodiments, the sleeve2132 is a short sleeve having a length in a range of 5 cm-120 cm. In oneembodiment, the sleeve 2132 is a short sleeve having a total length of60 cm. In some embodiments, the short sleeve 2132 functions to weighdown wire mesh structure 2131 and orient the wire mesh structure 2131 inthe correct direction toward the pylorus 2161. In addition, in oneembodiment, the device 2130 having a short sleeve 2132 is capable ofmoving freely within the patient's stomach 2160 after deployment. Theshort sleeve 2132 is capable of passing back and forth through thepylorus 2161 atraumatically. During situations when the device 2130 hasmoved such that the short sleeve 2132 is not positioned within thepylorus 2161 and duodenum 2170 but is rather in the stomach 2160 withthe remainder of the device 2130, the short sleeve also functions toimpede and regulate the flow of food into the pylorus 2161. This occursas food enters the device 2130 at the proximal end of the wire meshstructure 2131 and travels through the wire mesh structure 2131 andsleeve 2132, where its progress is slowed as it passes through thefunnel shaped sleeve 2132. At no time during its proper function is thedevice fixedly or permanently anchored to the wall of thegastrointestinal tract. After deployment, for a majority of itsfunctional time, at least a portion of the device or the entire deviceis free to move relative to the stomach or small intestine. As a resultof its included lumen, at no time during its normal function does thedevice completely or permanently block the passage of gastric contentsinto the small intestine for any clinically meaningful duration of time.Based on the shape of the sleeve, in various embodiments, the device canincrease, decrease, or have no effect on, gastric emptying.

FIG. 21B is an illustration of an intragastric device 2140 having anoval shaped wire mesh structure 2141 deployed in the gastrointestinaltract of a patient, in accordance with another embodiment of the presentspecification. The wire mesh structure 2141 is positioned in thepatient's stomach 2160 and includes an anti-migration collar 2144 towhich is attached a sleeve 2142. The sleeve 2142 includes a proximal,funnel shaped portion 2142 p which resides in the stomach, just proximalto the pylorus 2161. The sleeve 2142 also includes a distal,cylindrically shaped portion 2142 d which passes through the pylorus2161 and the duodenum 2170 and ends in the jejunum 2172, where itreleases the gastric contents passing through the intragastric device2140, effectively bypassing the pylorus 2161 and duodenum 2170. Inanother embodiment, the sleeve has a shorter length and ends in theduodenum such that gastric contents passing through the intragastricdevice bypass only the pylorus and a proximal portion of the duodenum.At no time during its proper function is the device fixedly orpermanently anchored to the wall of the gastrointestinal tract. Afterdeployment, fora majority of its functional time, at least a portion ofthe device or the entire device is free to move relative to the stomachor small intestine. As a result of its included lumen, at no time duringits normal function does the device completely or permanently block thepassage of gastric contents into the small intestine for any clinicallymeaningful duration of time. Based on the shape of the sleeve, invarious embodiments, the device can increase, decrease, or have noeffect on, gastric emptying.

FIGS. 21C and 21D are illustrations of several views 2121, 2122, 2123,2124 of a pylorus 2125 of a patient in an open state and a closed statewith and without a sleeve 2126 of an intragastric device passingtherethrough, in accordance with some embodiments of the presentspecification. In view 2121, the pylorus 2125 is closed and there is nosleeve extending therethrough. View 2122 shows a closed pylorus 2125with a sleeve 2126 extending therethrough. Views 2123 and 2124 showpartially open and fully open pylorus 2125 respectively, both with asleeve 2126 extending therethrough. In various embodiments, the sleeve2126 comprises a collapsible tubular reinforced membrane that opposesthe pyloric orifice inner diameter wall. In various embodiments, themaximum inner diameter of the sleeve 2126 ranges from 25 mm to 40 mmwith a wall thickness of approximately 0.2 mm. Any membrane, such assleeve 2126, passing through the pylorus will have a negligible butfinite cross-sectional area. In various embodiments, the cross-sectionalarea of the sleeve 2126 is approximately 15 mm², which is equivalent toa plug approximately 4.4 mm in diameter. In other words, the dynamiccross-sectional area of the pyloric orifice will always be reduced byapproximately 15 mm² when a sleeve 2126 is passing therethrough.

FIG. 22A is an illustration of an expanded wire mesh structure 2201 of afirst intragastric device 2200 in a post-deployment configuration. FIG.22B is an illustration of a constricted wire mesh structure 2221 of asecond intragastric device 2220 coupled to the distal end of animplantation catheter 2250. Looking at both FIGS. 22A and 22B, thesecond intragastric device 2220 also includes a sleeve 2222 coupled tothe distal end of the wire mesh structure 2221. The wire mesh structure2221 and sleeve 2222 of the second intragastric device 2220 have beencompressed and slid coaxially onto the distal end of the implantationcatheter 2250. In the pictured embodiment, the wire mesh structure 2221and sleeve 2222 are maintained in their compressed configuration by asuture line or thread 2225 that has been wrapped about both the wiremesh structure 2221 and sleeve. Once the device 2220 has been positionedin the stomach and duodenum of a patient, the suture line or thread 2225is unwound and the wire mesh structure 2221 and sleeve 2222 expand totheir deployed configuration. As the device 2220 expands, it is releasedfrom the catheter 2250. The catheter 2250 is then removed from thepatient. In another embodiment, the compressed wire mesh structure andsleeve are held in place over the implantation catheter via anoverlaying coaxial sheath. Upon deployment, the sheath is unzipped,pulled away, or torn in a vertical direction to release the device.

FIG. 23 is an illustration of an intragastric device 2300 with apartially constrained wire mesh structure 2301 on a delivery catheter2350, in accordance with one embodiment of the present specification.The device 2300 also includes a coupled sleeve 2302 and anti-migrationcomponent 2304. In the pictured embodiment, the proximal end of the wiremesh structure 2301 is still constricted by a suture or thread 2340. Thesleeve 2302, anti-migration component 2304, and a portion of the wiremesh structure 2301 have begun to expand as the constricting suture orthread has already been removed from these components.

FIG. 24A is an illustration of a first exemplary delivery device 2450for an intragastric device 2400, in accordance with one embodiment ofthe present specification. An intragastric device 2400, comprising acompressed wire mesh structure 2401 and sleeve 2402, is positionedcoaxially about the distal end of the delivery device or catheter 2450.A suture or thread 2440 is wrapped about the intragastric device 2400,maintaining the intragastric device 2400 in its compressedconfiguration. The catheter 2450 further includes a thread port 2458from which the suture or thread 2440 used to compress the intragastricdevice 2400 exits the proximal end of the catheter 2450. A physicianpulls on the free end 2459 of the suture or thread 2440 to release theintragastric device 2400. In one embodiment, the catheter 2450 alsoincludes a locking mechanism 2455 for locking the device 2450 inposition.

FIG. 24B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 24A, inaccordance with one embodiment of the present specification. At step2410, a compressed intragastric device is placed coaxially over thedistal end of the delivery device or catheter. The catheter is theninserted endoscopically into the patient and its distal end is advancedto the duodenum at step 2412. Then, at step 2414, the distal end of thecatheter is positioned such that the wire mesh structure of theintragastric device is in the stomach just proximal to the pylorus andthe sleeve of the device passes through the pylorus and into theduodenum. At step 2416, the physician pulls on the free end of thethread to remove the constricting thread from about the intragastricdevice, allowing the intragastric device to expand automatically.Finally, at step 2418, the catheter is slid coaxially away from theintragastric device and removed from the patient.

FIG. 25A is an illustration of a second exemplary delivery device 2550for an intragastric device 2500, in accordance with one embodiment ofthe present specification. An intragastric device 2500, comprising acompressed wire mesh structure 2501 and sleeve 2502, is positionedcoaxially about the distal end of the delivery device or catheter 2550.A zippered constraining sheath 2541 is coaxially positioned over theintragastric device 2500, maintaining the intragastric device 2500 inits compressed configuration.

FIG. 25B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 25A, inaccordance with one embodiment of the present specification. At step2510, a compressed intragastric device is placed coaxially over thedistal end of the delivery device or catheter. The catheter is theninserted endoscopically into the patient and its distal end is advancedto the duodenum at step 2512. Then, at step 2514, the distal end of thecatheter is positioned such that the wire mesh structure of theintragastric device is in the stomach just proximal to the pylorus andthe sleeve of the device passes through the pylorus and into theduodenum. At step 2516, a working tool is used to unzip the compressingsheath from about the intragastric device, allowing the intragastricdevice to expand automatically. Finally, at step 2518, the catheter isslid coaxially away from the intragastric device and removed from thepatient.

Alternatively, the sheath 2541 is a standard tubular sheath that ispulled off the intragastric device to release the intragastric device inthe desired position. FIG. 25C is a flow chart illustrating the stepsinvolved in delivering an intragastric device using a delivery devicecomprising a pull away sheath, in accordance with one embodiment of thepresent specification. At step 2550, a compressed intragastric device isplaced coaxially over the distal end of the delivery device or catheter.The catheter is then inserted endoscopically into the patient and itsdistal end is advanced to the duodenum at step 2552. Then, at step 2554,the distal end of the catheter is positioned such that the wire meshstructure of the intragastric device is in the stomach just proximal tothe pylorus and the sleeve of the device passes through the pylorus andinto the duodenum. At step 2556, a working tool is used to pull thecompressing sheath coaxially away from about the intragastric device,allowing the intragastric device to expand automatically. Finally, atstep 2558, the catheter is slid coaxially away from the intragastricdevice and removed from the patient.

FIG. 26A is an illustration of a third exemplary delivery device 2650for an intragastric device 2600, in accordance with one embodiment ofthe present specification. An intragastric device 2600, comprising acompressed wire mesh structure 2601 and sleeve 2602, is positionedcoaxially about the distal end of the delivery device or catheter 2650.A tear-away constraining sheath 2642 is coaxially positioned over theintragastric device 2600, maintaining the intragastric device 2600 inits compressed configuration.

FIG. 26B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 26A, inaccordance with one embodiment of the present specification. At step2610, a compressed intragastric device is placed coaxially over thedistal end of the delivery device or catheter. The catheter is theninserted endoscopically into the patient and its distal end is advancedto the duodenum at step 2612. Then, at step 2614, the distal end of thecatheter is positioned such that the wire mesh structure of theintragastric device is in the stomach just proximal to the pylorus andthe sleeve of the device passes through the pylorus and into theduodenum. At step 2616, a working tool is used to tear away acompressing sheath from about the intragastric device, allowing theintragastric device to expand automatically. Finally, at step 2618, thecatheter is slid coaxially away from the intragastric device and removedfrom the patient.

FIG. 26C is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 26A, inaccordance with another embodiment of the present specification. At step2620, a compressed intragastric device is placed coaxially over thedistal end of the delivery device or catheter. The catheter is theninserted endoscopically into the patient and its distal end is advancedto the stomach at step 2622. Then, at step 2624, the distal end of thecatheter is positioned such that the wire mesh structure and the sleeveof the intragastric device are both positioned proximal to the pylorus.At step 2626, a working tool is used to tear away a compressing sheathfrom about the intragastric device, allowing the intragastric device toexpand automatically. At step 2628, the catheter is slid coaxially awayfrom the intragastric device and removed from the patient. Finally, atstep 2630, gastric peristalsis pushes the sleeve of the intragastricdevice through the pylorus and into the duodenum.

FIG. 26D is a flow chart illustrating the steps involved in delivering awire mesh structure and sleeve separately and assembling an intragastricdevice within a patient's gastrointestinal tract. At step 2660, the wiremesh structure is delivered into the stomach of a patient by a firstcatheter. Then, at step 2662, the sleeve is delivered into the wire meshstructure by a second catheter. The distal end of the sleeve is thenextended through the distal opening in the wire mesh structure at step2664. Finally, at step 2666, the proximal end of the sleeve is coupledto the distal end of the wire mesh structure.

FIGS. 27A and 27B are illustrations of a fourth exemplary deliverydevice 2700 for an intragastric device, in accordance with oneembodiment of the present specification. The delivery device 2700includes a flexible elongate device body, or outer catheter 2704 with aproximal end, a distal end, and a lumen within. The distal end includesan opening 2703 and the proximal end is attached to a first handle 2705.The first handle 2705 is used for positioning the delivery device 2700in the gastrointestinal tract of a patient. A flexible plunger component2716 is positioned coaxially, and movable longitudinally, within thelumen of the device body 2704. The plunger 2716 includes a proximal end,a distal end, and also includes a lumen within. The distal tip 2714 ofthe plunger 2716 includes a mesh retention component 2719 comprising aplurality of fins 2715. The fins 2715 serve to securely hold the wiremesh structure 2701 of an intragastric device and push and pull the wiremesh structure 2701 as the plunger 2716 is moved back and forth withinthe device body 2704. A second handle 2706 is positioned at the proximalend of the plunger 2716 for moving the plunger 2716 longitudinallywithin the lumen of the device body 2704. Optionally, in one embodiment,the plunger 2716 includes a stopper 2718 which prevents the plunger 2716from moving too far in a distal direction. A flexible elongate rod, orinner catheter 2717 is positioned coaxially, and movable longitudinally,within the lumen of the plunger 2716. The rod 2717 includes a proximalend and a distal end. Positioned proximal the distal end of the rod 2717is a first spherical component or olive 2708 and positioned at thedistal end of the rod 2717 is a second spherical component or olive2709. The first spherical component or olive 2708 has a diameter similarto or greater than that of the second spherical component or olive 2709.Attached to the proximal end of the rod 2717 is a third handle 2707which is used for moving the rod 2717 longitudinally within the lumen ofthe plunger 2716. An intragastric device, comprising a wire meshstructure 2701 and a sleeve 2702, is positioned within the deliverydevice 2700 prior to deployment. The wire mesh structure 2701 is placedwith a side loop about the rod 2717 and distal to the tip 2714 of theplunger 2716, with a portion of the wire mesh structure 2701 hooked onthe fins 2715 of the tip 2714. In some embodiments, the rod 2717 passesthrough at least two openings in the wire mesh structure 2701 whereinthe openings do not lie along a center longitudinal axis of the wiremesh structure 2701. In one embodiment, the wire mesh structure 2701 iscompressed for positioning within the delivery device 2700 such that ithas a compressed length of approximately 20 cm. The sleeve 2702, whichis attached to the wire mesh structure 2701, is positioned distal to thewire mesh structure 2701 and proximal to the first spherical componentor olive 2708. The sleeve 2702 is folded upon itself 2 to 10 times andthen wrapped around the rod 2717. In one embodiment, the sleeve 2702 hasa length of 80 cm and is folded upon itself 3 times resulting in acompressed length of approximately 30 cm. The sleeve 2702 is not passedcoaxially over the rod 2717. Attached to the sleeve 2702 and looped onthe rod 2717 in a position distal to the first spherical component orolive 2708 are first and second ends, respectively, of a suture loop2713. The diameter of the suture loop 2713 about the rod is smaller thanthe diameter of the first spherical component or olive 2708 but greaterthan the diameter of the second spherical component or olive 2709. Whenthe rod 2717 is pushed out of the device body 2704, the first sphericalcomponent or olive 2708 pushes the suture loop 2713 which pulls theattached sleeve 2702 out of the device body 2704. When the deliverydevice 2700, along with the rod 2717, are removed from the patient'sgastrointestinal tract, the suture loop 2713 slips over the smallerdiameter second spherical component or olive 2709, allowing theintragastric device to remain in the patient. In one embodiment, thesuture loop 2713 is biodegradable and dissolves over time. In anotherembodiment, the suture loop 2713 is non-biodegradable. In otherembodiments, the suture loop 2713 is a biodegradable hook, ring, cone,or umbrella.

Optionally, in one embodiment, the delivery device 2700 further includesa balloon 2710 at the distal end of the device body 2704. A channel 2711extends along the length of the device body 2704 and includes an inputport 2712 at the proximal end of the device body 2704. The balloon 2710is inflated using the input port 2712 and channel 2711 to anchor thedelivery device within the patient's gastrointestinal tract. Anchoringprovides greater traction to the delivery device to allow for pushingand pulling during delivery of the intragastric device.

In some embodiments, the delivery device 2700 further includes aflushing or irrigation mechanism to reduce deployment forces duringdelivery.

In various embodiments, the delivery device or catheter has variablestiffness along its length. The delivery device is more flexible at itsdistal end and becomes less flexible along its length toward itsproximal end. In some embodiments, the delivery device has three zonesof flexibility: a proximal zone, a center zone, and a distal zone. Inone embodiment, the proximal zone has a length of 100 cm and aflexibility of 55D, the center zone has a length of 20 cm and aflexibility of 40D, and the distal zone has a length of 30 cm andflexibility of 35D. Optionally, in one embodiment, the distal zone issplit into two additional zones, comprising a more distal zone and aless distal zone. Both zones are 15 cm in length and the less distalzone has a flexibility of 35D while the more distal zone has aflexibility of 25D. In one embodiment, the proximal zone is braided andthe center and distal zones are coiled.

The delivery device includes atraumatic distal ends and the three handlesystem of the delivery device allows for a shorter overall device bodylength. In various embodiments, referring to FIG. 27B, the deliverydevice has the following dimensions: overall length ranging from 275cm-320 cm; length of said device body or outer catheter 2704 rangingfrom 100 cm-150 cm; length of said plunger 2716 ranging from 120 cm-150cm; length of said rod or inner catheter 2717 ranging from 275 cm-320cm; length of each handle 2705, 2706, 2707 equal to 10 cm; distancebetween said second spherical component or olive 2709 and said firstspherical component or olive 2708 ranging from 15 cm-30 cm; distancebetween said first handle 2705 and said second handle 2706 when in aninitial configuration before delivery equal to 60 cm; and, distancebetween said second handle 2706 and said third handle 2707 when in aninitial configuration before delivery equal to 50 cm. In someembodiments, the outer diameter of the device body or outer catheter2704 is 10 mm or less. In one embodiment, the delivery device isdeployable over a 0.035 inch guidewire. In various embodiments, theplunger 2716 and rod 2717 are sufficiently flexible to allow foratraumatic intestinal navigation. In some embodiments, a solid outercatheter can bend up to 80 degrees and is capable of navigating curveshaving a radius 30 mm-50 mm. In an embodiment, if a solid outer catheteris coiled into a radius of approximately 50 mm, the sleeve and mesh willkink or cinch in place and not deploy. Therefore, as depicted in FIG.27C, in some embodiments, the device body or outer catheter 2704comprises a flexible braided catheter. The flexible braided catheter iscapable of bending and coiling beyond the limits described above withoutcausing failure of deployment of the sleeve and wire mesh.

FIG. 27C is an illustration of a distal end of a delivery device 2700depicting a pilot olive, or first spherical component 2709 fornavigation, in accordance with one embodiment of the presentspecification. The pilot olive 2709 comprises a small sphere with ablunt outer surface attached to the distal end of the rod, or innercatheter 2717 of the delivery device 2700. The pilot olive 2709 guidesthe device 2700 during delivery and prevents kinking of the device 2700and trauma to surrounding body tissues. Referring to FIG. 27C, theportion of the inner catheter 2717 extending from the outer catheter2704 comprises a pilot component. The stiffness of the pilot componentis less than the stiffness of the distal portion of the outer catheter2704. In some embodiments, the pilot component has a variable stiffnesswith a stiffness close to the stiffness of the distal end of the outercatheter 2704 at its proximal end and a stiffness close to that of a0.035″ guidewire at its distal end.

FIG. 27D is an illustration of a portion of a delivery device 2700depicting a mesh retention component 2719, in accordance with oneembodiment of the present specification. The mesh retention component2719 comprises a plurality of fins 2715. The fins 2715 serve to securelyhold the wire mesh structure of an intragastric device and push and pullthe wire mesh structure as the plunger 2716 is moved back and forthwithin the device body 2704.

In one embodiment, the sleeve is only partially deployed duringdelivery. The wire mesh structure functions as an anchor to keep thedevice positioned. As the patient eats, the sleeve unfurls and becomesfully deployed due to the movements of the gastrointestinal tract.

FIG. 27E is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 27A, inaccordance with one embodiment of the present specification. At step2720, the delivery device is slid over a guidewire into position withina patient's gastrointestinal tract. At step 2721, a physician uses thefirst handle to position the distal end of the delivery device body in aduodenum of the patient. Optionally, at step 2722, the physicianinflates a balloon at the distal end of the device body to anchor thedelivery device in the patient's gastrointestinal tract. The physicianthen pushes the second handle, pushing in the plunger component, untilthe sleeve is pushed out of the device body at step 2723. Optionally,the plunger includes a stopper so the physician knows when to stoppushing the second handle. At this point, the sleeve has been advancedapproximately 20 cm, past the first spherical component and ispositioned just proximal to the second spherical component. The wiremesh structure is positioned just proximal to the first sphericalcomponent and the opening at the distal end of the device body. Then, atstep 2724, the physician pushes the third handle to advance the rodwithin the lumen of the plunger approximately 60 cm until the sleeve isfully deployed and is fully stretched or uncompressed. At step 2725, thephysician repositions the device by pulling it back approximately 5 to10 cm so that the distal end of the funnel section of the sleeve iswithin the stomach. Then, at step 2726, the physician pulls back on thefirst handle while holding the second handle steady to deploy the funnelsection of the sleeve and the wire mesh structure in the stomach. Thispulls the device body back while keeping the plunger in place, thusreleasing the wire mesh structure. The delivery device is then removedfrom the patient at step 2727, leaving the intragastric device deployedin the patient's gastrointestinal tract.

FIG. 28A is an illustration of a fifth exemplary delivery device 2830for an intragastric device, in accordance with one embodiment of thepresent specification. The delivery device 2830 includes a flexibleelongate device body, or outer catheter 2834 with a proximal end, adistal end, and a lumen within. The distal end includes an opening 2833and the proximal end is attached to an actuating mechanism 2835. Theactuating mechanism 2835 includes an actuator handle 2849 and anactuator trigger 2848 and is used to move the components of the deliverydevice relative to one another. The actuating mechanism is also used forpositioning the delivery device 2830 in the gastrointestinal tract of apatient. A flexible plunger component 2846 is positioned coaxially, andmovable longitudinally, within the lumen of the device body 2834. Theplunger 2846 includes a proximal end, a distal end, and also includes alumen within. The distal tip 2844 of the plunger 2846 includes a meshretention component 2819 comprising a plurality of fins 2845. The fins2845 serve to securely hold the wire mesh structure 2831 of anintragastric device and push and pull the wire mesh structure 2831 asthe plunger 2846 is moved back and forth within the device body 2834.The proximal end of the plunger 2846 is positioned within the actuatingmechanism wherein pulling the actuation trigger 2848 causes the plunger2846 to move back and forth longitudinally within the lumen of thedevice body 2834. A flexible elongate rod, or inner catheter 2847 ispositioned within the lumen of the plunger 2846. The rod 2847 includes aproximal end and a distal end. Positioned proximal the distal end of therod 2847 is a first spherical component or olive 2838 and positioned atthe distal end of the rod 2847 is a second spherical component or olive2839. The olives 2838, 2839 comprise spherical attachments which assistin guiding delivery of the intragastric device. The first sphericalcomponent or olive 2838 has a diameter greater than that of the secondspherical component or olive 2839. Attached to the proximal end of therod 2847 is a rod handle 2837 which is used for moving the rod 2847longitudinally within the lumen of the plunger 2846. An intragastricdevice, comprising a wire mesh structure 2831 and a sleeve 2832 ispositioned within the delivery device 2830 prior to deployment. Invarious embodiments, the sleeve is compressed axially. In otherembodiments, the sleeve is not compressed coaxially. The wire meshstructure 2831 is placed with a side loop about the rod 2847 and distalto the tip 2844 of the plunger 2846, with a portion of the wire meshstructure 2831 hooked on the fins 2845 of the tip 2844. The sleeve 2832,which is attached to the wire mesh structure 2831, is positioned distalto the wire mesh structure 2831 and proximal to the first sphericalcomponent or olive 2838. The sleeve 2832 is folded upon itself 2 to 10times and then wrapped around the rod 2847. The sleeve 2832 is notpassed coaxially over the rod 2847. Attached to the sleeve 2832 andlooped on the rod 2847 in a position distal to the first sphericalcomponent or olive 2838 is a suture loop 2843. The diameter of thesuture loop 2843 about the rod 2847 is smaller than the diameter of thefirst spherical component or olive 2838 but greater than the diameter ofthe second spherical component or olive 2839. When the rod 2847 ispushed out of the device body 2834, the first spherical component orolive 2838 pushes the suture loop 2843 which pulls the attached sleeve2832 out of the device body 2834. When the delivery device 2830, alongwith the rod 2847, are removed from the patient's gastrointestinaltract, the suture loop 2843 slips over the smaller diameter secondspherical component or olive 2839, allowing the intragastric device toremain in the patient. In one embodiment, the suture loop 2843 isbiodegradable and dissolves over time. In other embodiments, the sutureloop 2843 is a biodegradable hook, ring, cone, or umbrella.

Optionally, in one embodiment, the delivery device 2830 further includesa balloon 2840 at the distal end of the device body 2834. A channel 2841extends along the length of the device body 2834 and includes an inputport 2842 at the proximal end of the device body 2834. The balloon 2840is inflated using the input port 2842 and channel 2841 to anchor thedelivery device within the patient's gastrointestinal tract. Anchoringprovides greater traction to the delivery device to allow for pushingand pulling during delivery of the intragastric device.

FIG. 28B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 28A, inaccordance with one embodiment of the present specification. At step2850, the delivery device is slid over a guidewire into position withina patient's gastrointestinal tract. At step 2851, a physician uses theactuating mechanism to position the distal end of the delivery devicebody in a duodenum of the patient. Optionally, at step 2852, thephysician inflates a balloon at the distal end of the device body toanchor the delivery device in the patient's gastrointestinal tract. Thephysician then pulls on the actuation trigger until it locks a firsttime, pushing in rod handle, until the sleeve is pushed out of thedevice body at step 2853. Optionally, the plunger includes a stopper sothe physician knows when to stop pushing the second handle. At thispoint, the sleeve has been advanced approximately 20 cm, past the firstspherical component and is positioned just proximal to the secondspherical component. The wire mesh structure is positioned just proximalto the first spherical component and the opening at the distal end ofthe device body. Optionally, at step 2854, the physician pulls on thetrigger to advance the plunger approximately 60 cm until the sleeve isfully deployed and is fully stretched or uncompressed. At step 2855, thephysician repositions the device by pulling it back approximately 5 to10 cm so that the distal end of the funnel section of the sleeve iswithin the stomach. Then, at step 2856, the physician pulls on theactuation trigger again until it locks a second time. This pulls thedevice body back while keeping the plunger in place, thus releasing thefunnel section of the sleeve and the wire mesh structure. The deliverydevice is then removed from the patient at step 2857, leaving theintragastric device deployed in the patient's gastrointestinal tract.

FIG. 29A is an illustration of yet another exemplary delivery device2900 for an intragastric device, in accordance with one embodiment ofthe present specification. The delivery device 2900 of FIG. 29A differsfrom the delivery device 2700 depicted in FIG. 27A in that it includesonly two handles 2905, 2906 and a device body or outer catheter 2904 androd or inner catheter 2917. The delivery device 2900 of FIG. 29A doesnot include a separate plunger with its own handle. Instead, a plunger2916 is integrated with the second handle 2906 and coaxially envelopes aproximal portion of the inner catheter 2917. The delivery device 2900includes a flexible elongate device body, or outer catheter 2904 with aproximal end, a distal end, and a lumen within. The distal end includesan opening 2903 and the proximal end is attached to a first handle 2905.The first handle 2905 is used for positioning the delivery device 2900in the gastrointestinal tract of a patient. In one embodiment, the firsthandle 2905 includes a Y-connector. A flexible elongate rod, or innercatheter 2917 is positioned coaxially, and movable longitudinally,within the lumen of the outer catheter 2904. The rod 2917 includes aproximal end attached to a second handle 2906 and a distal end. Aflexible plunger component 2916 is positioned coaxially over a proximalportion of, and moves longitudinally with, the inner catheter 2917. Theplunger 2916 includes a proximal end also attached to second handle 2906and a distal end. The distal tip of the plunger 2916 includes a meshretention component 2919 comprising a plurality of fins 2915. The fins2915 serve to securely hold the wire mesh structure 2901 of anintragastric device and push and pull the wire mesh structure 2901 asthe plunger 2916 and inner catheter 2917 are moved back and forth withinthe outer catheter 2904. The second handle 2906 is positioned at theproximal end of the plunger 2916 and inner catheter 2917 for moving theplunger 2916 and inner catheter 2917 longitudinally within the lumen ofthe outer catheter 2904. Optionally, in one embodiment, the plungerincludes a stopper which prevents the plunger and inner catheter frommoving too far in a distal direction. Positioned proximal the distal endof the inner catheter 2917 is a first spherical component or olive 2908and positioned at the distal end of the inner catheter 2917 is a secondspherical component or olive 2909. The first spherical component orolive 2908 has a diameter greater than that of the second sphericalcomponent or olive 2909. An intragastric device, comprising a wire meshstructure 2901 and a sleeve 2902, is positioned within the deliverydevice 2900 prior to deployment. The wire mesh structure 2901 is placedwith a side loop about the rod 2917 and distal to the tip of the plunger2916, with a portion of the wire mesh structure 2901 hooked on the fins2915 of the retention component 2919. In some embodiments, the rod 2917passes through at least two openings in the wire mesh structure 2901wherein the openings do not lie along a center longitudinal axis of thewire mesh structure 2901. In one embodiment, the wire mesh structure2901 is compressed for positioning within the delivery device 2900 suchthat it has a compressed length of approximately 30 cm. The sleeve 2902,which is attached to the wire mesh structure 2901, is positioned distalto the wire mesh structure 2901 and proximal to the first sphericalcomponent or olive 2908. The sleeve 2902 is folded upon itself 2 to 10times and then wrapped around the inner catheter 2917. In oneembodiment, the sleeve 2902 has a length of 80 cm and is folded uponitself 3 times resulting in a compressed length of approximately 30 cm.The sleeve 2902 is not passed coaxially over the inner catheter 2917.Attached to the sleeve 2902 and looped on the inner catheter 2917 in aposition distal to the first spherical component or olive 2908 are firstand second ends, respectively, of a suture loop 2913. The diameter ofthe suture loop 2913 about the rod is smaller than the diameter of thefirst spherical component or olive 2908 but greater than the diameter ofthe second spherical component or olive 2909. When the inner catheter2917 is pushed out of the outer catheter 2904, the first sphericalcomponent or olive 2908 pushes the suture loop 2913 which pulls theattached sleeve 2902 out of the outer catheter 2904. When the deliverydevice 2900, along with the inner catheter 2917, are removed from thepatient's gastrointestinal tract, the suture loop 2913 slips over thesmaller diameter second spherical component or olive 2909, allowing theintragastric device to remain in the patient. In one embodiment, thesuture loop 2913 is biodegradable and dissolves over time. In otherembodiments, the suture loop 2913 is a biodegradable hook, ring, cone,or umbrella.

Optionally, in one embodiment, the delivery device 2900 further includesa balloon at the distal end of the device body. A channel extends alongthe length of the device body and includes an input port at the proximalend of the device body. The balloon is inflated using the input port andchannel to anchor the delivery device within the patient'sgastrointestinal tract. Anchoring provides greater traction to thedelivery device to allow for pushing and pulling during delivery of theintragastric device.

In some embodiments, the delivery device 2900 further includes aflushing or irrigation mechanism to reduce deployment forces duringdelivery.

In various embodiments, the delivery device or catheter has variablestiffness along its length. The delivery device is more flexible at itsdistal end and becomes less flexible along its length toward itsproximal end. In some embodiments, the delivery device has three zonesof flexibility: a proximal zone, a center zone, and a distal zone. Inone embodiment, the proximal zone has a length of 100 cm and aflexibility of 55D, the center zone has a length of 20 cm and aflexibility of 40D, and the distal zone has a length of 30 cm andflexibility of 35D. Optionally, in one embodiment, the distal zone issplit into two additional zones, comprising a more distal zone and aless distal zone. Both zones are 15 cm in length and the less distalzone has a flexibility of 35D while the more distal zone has aflexibility of 25D. In one embodiment, the proximal zone is braided andthe center and distal zones are coiled.

The delivery device includes atraumatic distal ends and the two handlesystem of the delivery device allows for a shorter overall device bodylength. In various embodiments, the delivery device has the followingdimensions: overall length ranging from 265 cm-310 cm; length of saiddevice body or outer catheter 2904 ranging from 100 cm-150 cm; length ofsaid plunger 2916 ranging from 120 cm-150 cm; length of said rod orinner catheter 2917 ranging from 265 cm-310 cm; length of each handle2905, 2906, 2907 equal to 10 cm; distance between said second sphericalcomponent or olive 2909 and said first spherical component or olive 2908ranging from 15 cm-30 cm; and, distance between said first handle 2905and said second handle 2906 when in an initial configuration beforedelivery equal to 110 cm. In some embodiments, the outer diameter of thedevice body or outer catheter 2904 is 10 mm or less. In one embodiment,the delivery device is deployable over a 0.035 inch guidewire. Invarious embodiments, the plunger 2916 and inner catheter 2917 aresufficiently flexible to allow for atraumatic intestinal navigation. Insome embodiments, a solid outer catheter can bend up to 80 degrees andis capable of navigating curves having a radius 30 mm-50 mm. In anembodiment, if a solid outer catheter is coiled into a radius ofapproximately 50 mm, the sleeve and mesh will kink or cinch in place andnot deploy. Therefore, in some embodiments, the outer catheter 2904comprises a flexible braided catheter. The flexible braided catheter iscapable of bending and coiling beyond the limits described above withoutcausing failure of deployment of the sleeve and wire mesh.

In one embodiment, the sleeve is only partially deployed duringdelivery. The wire mesh structure functions as an anchor to keep thedevice positioned. As the patient eats, the sleeve unfurls and becomesfully deployed due to the movements of the gastrointestinal tract.

In some embodiments, the outer catheter has a variable stiffness alongits length and the inner catheter, coaxially positioned inside the outercatheter, includes an atraumatic distal end and a lumen for receiving aguiding device. Prior to delivery, an intragastric device is positionedin a space between the inner catheter and the outer catheter. The innercatheter further includes a flexible extension having a length of atleast 5 cm at its distal end which extends beyond a distal end of theouter catheter. In some embodiments, the guiding device is a guidewire.In other embodiments, the guiding device is an endoscope for over thescope delivery. In some embodiments, the atraumatic distal end of theinner catheter is a ball-tip. In some embodiments, the inner catheterhas a variable stiffness along its length. In some embodiments, saidflexible extension includes a proximal end and a distal end and has avariable stiffness along its length wherein the stiffness varies betweena stiffness of a guidewire at said distal end to a stiffness of saidinner catheter at said proximal end. In other embodiments, the stiffnessof the flexible extension is constant along its length.

FIG. 29B is a cross sectional illustration of a pre-deployment coaxialarrangement of a sleeve 2935 of an intragastric device within a deliverydevice 2930, in accordance with one embodiment of the presentspecification. The delivery device 2930 comprises an inner catheter 2933positioned coaxially within a lumen 2936 of an outer catheter 2937. Theinner catheter 2933 includes a guide wire port 2932 for insertion of aguide wire to assist in guiding delivery. In various embodiments, theguide wire is a super stiff guide wire having a diameter in a range of0.035 to 0.038 inches. In the arrangement depicted in FIG. 29B, thesleeve 2935 is depicted around the inner catheter 2933 such that theinner catheter 2933 is positioned within a lumen 2934 of the sleeve2935.

FIG. 29C is a cross sectional illustration of a pre-deployment coaxialarrangement of a sleeve of 2935 an intragastric device within a deliverydevice 2930, in accordance with another embodiment of the presentspecification. The delivery device 2930 comprises an inner catheter 2933positioned coaxially within a lumen 2936 of an outer catheter 2937. Theinner catheter 2933 includes a guide wire port 2932 for insertion of aguide wire to assist in guiding delivery. In the arrangement depicted inFIG. 29C, the sleeve 2935 is depicted adjacent the inner catheter 2933such that the inner catheter 2933 is positioned outside of a lumen 2934of the sleeve 2935.

FIG. 29D is a cross sectional illustration of a pre-deployment coaxialarrangement of a sleeve 2933 of an intragastric device within a deliverydevice 2930 depicted over an endoscope 2939, in accordance with oneembodiment of the present specification. The delivery device 2930comprises an inner catheter 2933 positioned coaxially within a lumen2936 of an outer catheter 2937. The inner catheter 2933 includes anendoscope port 2938, within which is positioned an endoscope 2939, toassist in guiding delivery. In the arrangement depicted in FIG. 29D, thesleeve 2935 is depicted around the inner catheter 2933 such that theinner catheter 2933 is positioned within a lumen 2934 of the sleeve2935.

In some embodiments, a system for delivering an intragastric device to agastrointestinal tract of a patient comprises: a porous mesh structurehaving a first lumen; a sleeve attached to said porous mesh structureand having a second lumen; and, a coaxial catheter system comprising anouter catheter and an inner catheter, wherein, prior to delivery, saidporous mesh structure and said sleeve are constrained into a spacebetween said outer and inner catheters wherein the outer catheter coversa substantial portion of the intragastric device and the inner catheterpasses within a majority of the first lumen of the mesh but outside of amajority of the second lumen of the sleeve. In some embodiments, theinner catheter is operationally attached to the sleeve at a distal endof the inner catheter such that, when actuated, the inner catheterpushes the sleeve out of the coaxial catheter system and is thendetached from the sleeve to deliver the intragastric device in thegastrointestinal tract.

FIG. 29E is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 29A, inaccordance with one embodiment of the present specification. At step2920, the delivery device is slid over a guidewire into position withina patient's gastrointestinal tract. At step 2921, a physician uses thefirst handle to position the distal end of the delivery device body in aduodenum of the patient. Optionally, at step 2922, the physicianinflates a balloon at the distal end of the device body to anchor thedelivery device in the patient's gastrointestinal tract. The physicianthen pushes the second handle (approximately 60 cm) to advance theplunger and inner catheter until the sleeve is pushed out of thedelivery device body and fully deployed at step 2923. Optionally, theplunger includes a stopper so the physician knows when to stop pushingthe second handle. At step 2924, the physician repositions the device bypulling it back approximately 5 to 10 cm so that the distal end of thefunnel section of the sleeve is within the stomach. Then, at step 2925,the physician pulls back on the first handle while holding the secondhandle steady to deploy the funnel section of the sleeve and the wiremesh structure in the stomach. This pulls the device body back whilekeeping the plunger and inner catheter in place, thus releasing the wiremesh structure. The delivery device is then removed from the patient atstep 2926, leaving the intragastric device deployed in the patient'sgastrointestinal tract.

FIG. 30A is an illustration of a seventh exemplary delivery device 3000for an intragastric device, in accordance with one embodiment of thepresent specification. The delivery device 3000 comprises a coaxialdelivery system having flexible outer catheter 3002 and flexible innercatheter 3001 shafts on which an intragastric device is preloaded. Theouter catheter 3002 includes a proximal end and a distal end and a lumenwithin. The inner catheter 3001 is positioned within the lumen of theouter catheter 3002 and also includes a proximal end and a distal endand a lumen within. The lumen of the inner catheter 3001 is configuredto receive a guide wire. In various embodiments, the delivery device3000 is approximately 3 meters in length and is used to deliver anintragastric device trans-orally into the stomach and duodenum orjejunum of a patient. The delivery device 3000 has a variable stiffnessalong its length providing sufficient flexibility to track through thesmall intestinal loops while also having sufficient pushability toprevent gastric looping. In various embodiments, the outer catheter 3002has a length of approximately 1.5 meters. In some embodiments, a distalportion of the outer catheter 3002 includes a lubricious hydrophiliccoating which can be activated just prior to delivery to easenavigation. In one embodiment, the coating covers approximately thedistal 0.65 meters of the outer catheter 3002. The proximal end of thedevice 3000 includes a proximal portion of the inner catheter 3001 notcovered by the outer catheter 3002. A pair of stopping mechanisms 3004,3006 are positioned on the inner catheter 3001 as further described withreference to FIGS. 30E and 30G. A first handle 3003, having a proximalend, a distal end, and lumen configured to receive a guide wire, isattached to the proximal end of the inner catheter 3001. A second handle3008, having a proximal end, a distal end, and a lumen configured toreceive said inner catheter 3001, is attached to the proximal end of theouter catheter 3002 and is positioned coaxially about, and slidablyover, the inner catheter 3001. Movement of the second handle 3008proximally and distally relative to the first handle 3003 results insliding of the outer catheter 3002 over the inner catheter 3001proximally and distally.

Extending distally from the distal end of the inner catheter 3001 is apilot component 3007. The pilot component comprises an elongateultra-flexible rod having a proximal end and a distal end. The proximalend of the pilot component includes a proximal spherical component, orolive as described with reference to FIGS. 30D and 30E below. The distalend of the pilot component 3007 includes a distal spherical component,or olive, as described further with reference to FIGS. 30D and 30Fbelow. In some embodiments, the pilot component 3007 is also coveredwith a lubricious hydrophilic coating.

FIG. 30B is an illustration of one exemplary embodiment of an outercatheter 3050 for use in the delivery device of FIG. 30A. The outercatheter 3050 includes three segments of varying stiffness, each havinga proximal end, a distal end, and a lumen: a proximal segment 3051, acenter segment 3052, and a distal segment 3053. Attached to the proximalend of the proximal segment 3051 is the second handle 3054. Attached tothe distal end of the distal segment 3053 is a soft tip 3055. Both thesecond handle 3054 and soft tip 3055 include lumens for receiving aninner catheter. In one embodiment, the outer catheter 3050 includes afirst radiopaque marker 3056 at the junction of the soft tip 3055 withthe distal segment 3053 and a second radiopaque marker 3057 on thecenter segment 3052, approximately 4-6 cm from the junction of thecenter segment 3052 with the proximal segment 3051. In variousembodiments, the proximal segment 3051 has a length of approximately 85cm and a stiffness which is 120% of the stiffness of the center segment3052. In various embodiments, the center segment 3052 has a length in arange of approximately 52-54 cm. In various embodiments, the distalsegment 3053 has a length in a range of approximately 11-13 cm and astiffness which is 80% of the stiffness of the center segment 3052. Invarious embodiments, the outer catheter 3050 has an overall length in arange of 150-152 cm, not including the second handle 3054 or soft tip3055. In one embodiment, the second handle 3054 has a length of 10 cm.In one embodiment, the soft tip 3055 has a length of 0.5 cm. Duringdelivery, the second handle 3054 is positioned outside the patient'sbody. In some embodiments, during delivery, approximately the proximal50 cm of the proximal segment 3051 is positioned in the esophagus. Insome embodiments, during delivery, approximately the distal 35 cm of theproximal segment 3051 and the proximal 4-6 cm of the center segment 3052are positioned in the stomach. In some embodiments, during delivery,approximately the distal 48 cm of the center segment 3052 and theentirety of the distal segment 3053 and soft tip 3055 are positioned inthe intestine.

FIG. 30C is an illustration of another embodiment of an outer catheter3070 depicting the dimensions a compressed sleeve 3062 and compressedwire mesh structure 3061 of an intragastric device 3060 relative to thedimensions of the outer catheter 3070. The outer catheter 3070 of FIG.30C includes only a proximal segment 3071 and a distal segment 3073. Thedistal segment 3073 has a length in a range of 63-67 cm, with 59-61 cmpositioned in the intestine and 4-6 cm positioned in the stomach. Thecompressed sleeve 3062 has a length in a range of 54-56 cm, is containedfully within the distal segment 3073, and is positioned entirely withinthe intestine. The compressed wire mesh structure 3061 has a length in arange of approximately 29-31 cm. Approximately 9-11 cm of wire meshstructure 3061 is contained within the proximal end of the distalsegment 3073 and 19-21 cm of the wire mesh structure 3061 is containedwithin the distal end of the proximal segment 3071. Approximately 4-6 cmof the wire mesh structure 3061 is positioned in the intestine and 24-26cm of the wire mesh structure is positioned in the stomach.

FIG. 30D is a close up illustration of the distal end of the deliverydevice 3000 of FIG. 30A, depicting the pilot component 3007 and proximal3011 and distal 3013 spherical components. The proximal sphericalcomponent 3011 is shaped to be atraumatic and includes a radiopaquemarker 3012 for radiographic visualization during delivery. The distalspherical component 3013 is configured in a ball-tip shape and is alsodesigned to be atraumatic to body tissues. The design of the pilotcomponent 3007 and proximal 3011 and distal 3013 spherical components isconfigured to facilitate atraumatic and easy ‘over-the-guide wire’tracking through the intestinal loops. The stiffness of the pilotcomponent 3007 is less than the stiffness of the distal portion of theouter catheter. In some embodiments, the pilot component 3007 has avariable stiffness with a stiffness close to the stiffness of the distalend of the outer catheter at its proximal end and a stiffness close tothat of a 0.035″ guidewire at its distal end.

FIG. 30E is an illustration of the proximal end of the delivery deviceof FIG. 30A, depicting the outer catheter 3002 retracted to a firststopping mechanism 3004. During delivery of an intragastric device whichhas been preloaded on the delivery device, a user steadies the firsthandle 3003 to hold inner catheter 3001 in place while using the secondhandle 3008 to retract, or slide proximally, the outer catheter 3002over the inner catheter 3001. The outer catheter 3002 is retracted untila proximal end of the second handle 3008 contacts a first stoppingmechanism 3004. A second stopping mechanism 3006 is also positioned onthe inner catheter 3001, proximal to the first stopping mechanism 3004.In some embodiments, the stopping mechanisms 3004, 3006 comprise plasticrings firmly secured to the inner catheter using wing nuts 3004 a, 3006a. In some embodiments, the first handle 3003 includes a first port 3013for injection of a fluid, such as saline or water, for flushing thelumen of the inner catheter 3001. In some embodiments, the second handle3008 includes a second port 3018 for injection of a fluid, such assaline or water, for flushing the lumen of the outer catheter 3002.

FIG. 30F is an illustration of one embodiment of a sleeve 3022 of anintragastric device partially deployed corresponding to the outercatheter 3002 position depicted in FIG. 30E. Referring to FIGS. 30E and30F simultaneously, when the outer catheter 3002 has been retracted suchthat the proximal end of the second handle 3008 is in contact with thefirst stopping mechanism 3004, the sleeve 3022 has been partiallydeployed as depicted in FIG. 30F. The portion of the sleeve 3022deployed is the cylindrical distal portion 1622 d as described withreference to FIG. 16D. This is the portion of the sleeve 3022 whichresides in the small intestine of the patient. The outer catheter 3002has been retracted to the junction point 1622 j of the sleeve describedin FIG. 16D. As pictured in FIG. 30F, in some embodiments, the sleeve3022 is wrapped coaxially around the inner catheter 3001 of the deliverydevice. In other words, the inner catheter 3001 does not pass throughthe lumen of the sleeve 3022. In one embodiment, the distal end of theouter catheter 3002 includes a radiopaque marker 3009 to ensure properplacement of the delivery device under radiographic visualization.

FIG. 30G is an illustration of the proximal end of the delivery deviceof FIG. 30A, depicting the outer catheter 3002 retracted to a secondstopping mechanism 3006. The first stopping mechanism has been removedto allow further retraction of the outer catheter 3002. Continuing withdelivery of an intragastric device, the user steadies the first handle3003 to hold inner catheter 3001 in place while using the second handle3008 to further retract the outer catheter 3002 over the inner catheter3001. The outer catheter 3002 is retracted until a proximal end of thesecond handle 3008 contacts the second stopping mechanism 3006.

FIG. 30H is an illustration of one embodiment of a wire mesh structure3021 of an intragastric device partially deployed corresponding to theouter catheter 3002 position depicted in FIG. 30G. Referring to FIGS.30G and 30H simultaneously, when the outer catheter 3002 has beenretracted such that the proximal end of the second handle 3008 is incontact with the second stopping mechanism 3006, the wire mesh structure3021 has been partially deployed as depicted in FIG. 30H. Theanti-migration collar 3024 of the wire mesh structure 3021 has beendeployed and, as a result of its shape memory properties, has everted toits post-deployment configuration from its pre-deployment configurationas depicted in FIG. 11D. The proximal end of the now fully deployedsleeve 3022 is depicted attached to the anti-migration collar 3024. Aspictured in FIG. 30H, in some embodiments, the inner catheter 3001 ispassed through spaces between the wires of wire mesh structure 3021along a side of said structure 3021. In other words, the inner catheter3001 does not pass through the center of the wire mesh structure 3021.

FIG. 30I is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery device of FIG. 30A, inaccordance with one embodiment of the present specification. At step3030, optionally, the distal end of the delivery device is wetted toactivate a lubricious hydrophilic coating, which will ease insertion andnavigation of the delivery device. The delivery device is then slid overa guide wire and into a patient's gastrointestinal tract at step 3032.Fluoroscopy is used at step 3034 to determine the location of the distalend of the outer catheter to ensure correct positioning of the deliverydevice. While the first handle is held firmly to keep the inner catheterin place, the outer catheter is retracted to the first stoppingmechanism to deploy and position a portion of the sleeve of a pre-loadedintragastric device within an intestinal portion of the patient'sgastrointestinal tract at step 3036. Then, at step 3038, the entiredelivery device is retracted until the distal end of the outer catheteris positioned just proximal to the pylorus. The first stopping mechanismis removed from the inner catheter at step 3040. While the first handleis held firmly to keep the inner catheter in place, the outer catheteris retracted to the second stopping mechanism to deploy and position aportion of the sleeve and a portion of the wire mesh structure of theintragastric device within a stomach portion of the patient'sgastrointestinal tract at step 3042. At step 3044, the second stoppingmechanism is removed from the inner catheter. While the first handle isheld firmly to keep the inner catheter in place, the outer catheter isretracted to the first handle to deploy and position all of the wiremesh structure within the stomach portion of the patient'sgastrointestinal tract at step 3046. The delivery device is then removedfrom the patient at step 3048.

FIG. 31A is an illustration of a wire mesh structure 3101 of anintragastric device 3100 being loaded onto a delivery device, inaccordance with one embodiment of the present specification. Referringto FIG. 31A, a portion of the inner catheter 3131 and pilot component3137 of the delivery device are depicted. The delivery device includes aproximal spherical component 3135 at the transition from inner catheter3101 to pilot component 3137. The wire mesh structure 3101 includes asleeve 3102 attached to its anti-migration collar 3104. When loading theintragastric device 3100 onto the delivery device, the pilot component3137 is passed through an off-center opening between the wires of thewire mesh structure 3101 such that the proximal spherical component 3135is positioned just distal to the wire mesh structure 3101 and the innercatheter 3131 lies within the internal volume of the wire mesh structure3101.

FIG. 31B is an illustration of the wire mesh structure 3101 of FIG. 31Afurther loaded onto the delivery device. The proximal end of the wiremesh structure 3101 has been compressed and is now contained within thedistal end of the outer catheter 3132 of the delivery device. Theproximal spherical component is no longer visible as the wire meshstructure 3101 has been advanced proximally along the inner catheter3131. Referring to FIG. 31B, the inner catheter is depicted exiting thewire mesh structure 3101 through an opening offset from center of thewire mesh structure 3101. The sleeve is then wrapped coaxially about theinner catheter as described with reference to FIG. 31C. In anotherembodiment, the inner catheter (and attached pilot component) continueswithin the wire mesh structure and exits through an opening in a side ofthe proximal, funnel shaped portion of the sleeve. In anotherembodiment, the inner catheter continues within the wire mesh structureand exits through an opening in a side of the distal, cylindricallyshaped portion of the sleeve. In yet another embodiment, the innercatheter continues within the wire mesh structure, passes through theentire sleeve, and exits through the opening in the distal end of thesleeve.

FIG. 31C is an illustration of the wire mesh structure 3101 of FIG. 31Aloaded onto the delivery device such that only the anti-migration collar3104 remains to be loaded. FIG. 31D is an illustration of the wire meshstructure of FIG. 31A fully loaded onto the delivery device. Referringto FIG. 31D, the wire mesh structure is no longer visible as it is fullycontained within the distal end of the outer catheter 3132. The sleeve3102 is depicted wrapped coaxially about the inner catheter 3131.

FIG. 31E is an illustration of a sleeve 3102 of the intragastric deviceof FIG. 31A partially loaded onto the delivery device. A portion of thesleeve 3102, wrapped coaxially about the inner catheter 3131, is visibleextending from the distal end of the outer catheter 3132. FIG. 31F is anillustration of the intragastric device of FIG. 31A fully loaded ontothe delivery device. The proximal spherical component 3135 is positionedat the distal end of the outer catheter 3132. In one embodiment, aplurality of sutures 3105 extending from the distal end of the sleeveare tied about the proximal spherical component 3135 to maintain theintragastric device in place until ready for delivery. Prior todelivery, the sutures 3105 are undone so the intragastric device may bedeployed.

FIG. 32A is an illustration of a retrieval device 3200 for removing anintragastric device in accordance with another embodiment of the presentspecification. The retrieval device 3200 includes a flexible outer tube3202 comprising an elongate body having a proximal end, a distal end,and a lumen within. A first handle 3212 is attached to the proximal endand an opening 3222 is positioned at the distal end of the outer tube3202. A flexible inner member 3204 comprising an elongate body with aproximal end and a distal end is disposed within the lumen of the outertube 3202. In one embodiment, the inner member 3204 comprises a flexiblemetal wire. A second handle 3214 is attached to the proximal end and aretrieval mechanism 3224 is formed from the distal end of the innermember 3204. In one embodiment, the retrieval mechanism 3224 comprises ahook. In one embodiment, the hook is lockable.

FIG. 32B is a flow chart illustrating the steps involved in removing anintragastric device from a patient using the retrieval device of FIG.32A, in accordance with one embodiment of the present specification. Atstep 3232, a physician inserts the outer tube of the retrieval deviceinto a working channel of an endoscope inserted into a patient. At thispoint, the retrieval mechanism at the distal end of the inner member iscontained within the distal end of the outer tube. At step 3234, thephysician holds the first handle securely to position the retrievaldevice within the gastrointestinal tract of the patient. Then, at step3236, the physician pushes on the second handle to extend the retrievalmechanism through the opening and beyond the distal end of the outertube. The physician manipulates the second handle to grasp a proximalend of the intragastric device with the retrieval mechanism at step3238. In one embodiment, the proximal end of the intragastric deviceincludes a set of staggered nodes, as depicted as nodes 1615 withreference to FIG. 16B, to ease grasping with the retrieval mechanism.Once the intragastric device has been secured by the retrievalmechanism, the physician pulls on the second handle to pull theretrieval mechanism and at least a portion of the attached intragastricdevice into the distal end of the outer tube at step 3240. Theintragastric device is composed of a shape memory metal so that it iseasily compressible to a size capable of fitting into said outer tube.Optionally, at step 3242, the physician actuates a locking mechanism onthe retrieval device to prevent the retrieval mechanism and attachedintragastric device from slipping out of the distal end of the outertube. Finally, at step 3244, the physician removes the retrieval deviceand attached intragastric device from the patient.

FIG. 33A is an illustration of an embodiment of an intragastric device3300 in an exemplary post-deployment configuration having a dumbbellshape. The device 3300 includes a first, upper wire mesh 3361 at itsproximal end and a second, lower wire mesh 3362 at its distal end. Theinternal volumes of the two wire meshes 3361, 3362 are in fluidcommunication with one another. In various embodiments, the size of thesecond wire mesh 3362 is equal to or smaller than the size of the upperwire mesh 3361. The device 3300 further includes a first opening 3363 atthe proximal end of the upper wire mesh 3361 and a second, largeropening 3364 at the distal end of the lower wire mesh 3362. Food entersthe device 3300 at the first opening 3363, travels through the internalvolume of the upper wire mesh 3361, into and through the internal volumeof the lower wire mesh 3362, and exits through the second opening 3364.In one embodiment, the wire mesh of the lower wire mesh portion 3362 isan extension of the wire mesh of the upper wire mesh portion 3361. Inanother embodiment, the two wire mesh portions 3361, 3362 are comprisedof separate wire mesh structures which are then attached prior todeployment. In the pictured embodiment, the device 3300 includes amembrane 3367 covering the entire outer surface of the device 3300 withthe exception of the two openings 3363, 3364.

FIG. 33B is an illustration of an embodiment of an intragastric device3320 having a double-wire mesh structure wherein the lower wire mesh isformed from an everted anti-migration component 3324. The device 3320has a dumbbell shaped structure similar to the double-mesh devicestructure embodiments discussed in the present specification andfunctions similarly to those devices. The upper wire mesh 3322 issimilar to the wire mesh structure 210 of FIG. 2B and the lower meshstructure is similar to the anti-migration collar 214 of FIG. 2B exceptthat the lower mesh structure 3324 is larger and everts or curvescompletely in a proximal direction to form said lower mesh structure3324 as depicted in FIG. 33B. The first wire mesh structure 3322comprises a plurality of free ends extending from its lower portion, orbase. One portion of said plurality of free ends are curved uponthemselves to create the everted portion 3324 on the right side while asecond portion of said plurality of free ends are curved upon themselvesto create the everted portion 3324 on the left side. It should beappreciate that this eversion can occur around the entire periphery ofthe first wire structure thereby creating a torus, which may beelongated, elliptical, or egg shape.

In various embodiments, the device 3300 has a total length rangingbetween 50 and 500 mm. In a preferred embodiment, the device 3300 has atotal length of 180 mm. In various embodiments, the upper wire mesh 3361has a length ranging between 30 and 250 mm. In a preferred embodiment,the upper wire mesh 3361 has a length of 140 mm. In various embodiments,the lower wire mesh 3362 has a length ranging between 1 and 250 mm. In apreferred embodiment, the lower wire mesh 3362 has a length of 10 mm. Invarious embodiments, the upper wire mesh 3361 has a width rangingbetween 30 and 300 mm. In a preferred embodiment, the upper wire mesh3361 has a width of 120 mm. In various embodiments, the lower wire mesh3362 has a width ranging between 10 and 300 mm. In a preferredembodiment, the lower wire mesh 3362 has a width of 60 mm. In variousembodiments, the first opening 3363 has a diameter ranging between 5 and50 mm. In a preferred embodiment, the first opening 3363 has a diameterof 20 mm. In various embodiments, the second opening 3364 has a diameterranging from 10 to 75 mm. In a preferred embodiment, the second opening3364 has a diameter of 30 mm.

FIG. 34A is an illustration of another exemplary double-wire meshintragastric device 3400 a in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3401 positionedon top of a second wire mesh structure 3411 and a sleeve 3402 coupled tothe distal end of the second wire mesh structure 3411. A firstanti-migration component 3404 at the base of the first wire meshstructure 3401 rests inside the second wire mesh structure 3411 andfunctions to couple the two wire mesh structures 3401, 3411 together.The first anti-migration component 3404 also helps to prevent the secondwire mesh structure 3411 from being compressed by gastric contractionsand keeps the device 3400 a out of the pylorus. A second anti-migrationcomponent 3414, at the base of the second wire mesh structure 3411, actsto prevent the entirety of the device 3400 a from being passed throughthe pylorus. Food first passes through openings in the top of thecombined intragastric device 3400 a and is sequestered in the first wiremesh structure 3401. The food then slowly passes into, and issequestered in, the second wire mesh structure 3411. Finally, the foodslowly releases through the openings in the bottom of the combinedintragastric device 3400 a into a sleeve 3402 attached to distal end ofthe second wire mesh structure 3411 that bypasses the pylorus to releasethe food into the small intestine. In one embodiment, there is noattached sleeve 3402 and the food is released through the openings inthe bottom of the combined intragastric device 3400 a back into thestomach. The combined wire mesh structures 3401, 3411 work together tooccupy an increased volume in a patient's stomach and further delay thepassage of food through the gastrointestinal tract. The combined twowire mesh structures 3401, 3411 also act to induce satiety even morequickly and induce a longer lasting satiety than a single mesh structuredevice. The two wire-mesh structures are able to move relative to eachother as compared to a single structure, allowing them to adjust betterto the shape of the stomach, resulting in better tolerability and/orless complications.

FIG. 34B is an illustration of another exemplary double-wire meshintragastric device 3400 b in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3421 positionedon top of a second wire mesh structure 3431. The two wire meshstructures 3421, 3431 work together to occupy an increased volume in apatient's stomach and further delay the passage of food through thegastrointestinal tract. The two wire-mesh structures are able to moverelative to each other as compared to a single structure, allowing themto adjust better to the shape of the stomach, resulting in bettertolerability and/or less complications.

FIG. 34C is an illustration of another exemplary double-wire meshintragastric device 3400 c in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3451 positionedon top of a second wire mesh structure 3461. An anti-migration component3464 at the base of the second wire mesh structure 3461 acts to preventthe entirety of the device 3400 c from being passed through the pylorus.The two wire mesh structures 3451, 3461 work together to occupy anincreased volume in a patient's stomach and further delay the passage offood through the gastrointestinal tract. The two wire-mesh structuresare able to move relative to each other as compared to a singlestructure, allowing them to adjust better to the shape of the stomach,resulting in better tolerability and/or less complications.

FIG. 34D is an illustration of another exemplary double-wire meshintragastric device 3400 d in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3471 positionedon top of a second wire mesh structure 3481. A first anti-migrationcomponent 3474 at the base of the first wire mesh structure 3471 restsinside the second wire mesh structure 3481 and functions to couple thetwo wire mesh structures 3471, 3481 together. The first anti-migrationcomponent 3474 also helps to prevent the second wire mesh structure 3481from being compressed by gastric contractions and keeps the device 3400d out of the pylorus. A second anti-migration component 3484 at the baseof the second wire mesh structure 3481 acts to prevent the entirety ofthe device 3400 d from being passed through the pylorus. The two wiremesh structures 3471, 3481 work together to occupy an increased volumein a patient's stomach and further delay the passage of food through thegastrointestinal tract.

FIG. 34E is an illustration of another exemplary double-wire meshintragastric device 3400 e in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3493 positionedon top of a second wire mesh structure 3495. An anti-migration component3497 at the base of the first wire mesh structure 3493 rests inside thesecond wire mesh structure 3495 and functions to couple the two wiremesh structures 3493, 3495 together. The anti-migration component 3497also helps to prevent the second wire mesh structure 3495 from beingcompressed by gastric contractions and keeps the device 3400 e out ofthe pylorus. The two wire mesh structures 3493, 3495 work together tooccupy an increased volume in a patient's stomach and further delay thepassage of food through the gastrointestinal tract.

In various embodiments, any of the double-wire mesh intragastric devicesof FIGS. 34B to 34E further includes a sleeve attached to the distal endof the second wire mesh structure. In various embodiments, theanti-migration components, or collars, of the devices of the presentspecification have a length ranging from 1 mm to 100 mm and an outerdiameter of 25 mm to 75 mm for a ratio of length to outer diameterranging from 0.01 to 4. In one embodiment, the anti-migration component,or collar, has a length equal to 15 mm and an outer diameter of 60 mmfor a ratio of length to outer diameter of 0.25. In various embodiments,the wire meshes of the intragastric devices of the present specificationare configured to be fatigue resistant for a period of at least sixmonths, wherein fatigue resistant is defined as break resistant underintended use.

FIG. 34F is an illustration of another exemplary double-wire meshintragastric device 3400 f in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3491 positionedon top of a second wire mesh structure 3499 and a sleeve 3492 coupled tothe distal end of the second wire mesh structure 3499. An anti-migrationcomponent 3494 at the base of the second wire mesh structure 3499 actsto prevent the entirety of the device 3400 f from being passed throughthe pylorus. The two wire mesh structures 3491, 3499 work together tooccupy an increased volume in a patient's stomach and further delay thepassage of food through the gastrointestinal tract.

FIGS. 34G and 34H are illustrations of exemplary double-wire meshintragastric devices 3400 g in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 3403 positionedon top of a second wire mesh structure 3405 and a sleeve 3407 coupled tothe distal end of the second wire mesh structure 3405. A firstanti-migration feature 3409 at the base of the first wire mesh structure3403 functions to couple the two wire mesh structures 3403, 3405together. The first anti-migration feature 3409 also helps to preventthe second wire mesh structure 3403 from being compressed by gastriccontractions when the first wire mesh structure 3405 is being compressedand keeps the device 3400 f from passing through the pylorus in itsentirety. A second anti-migration component 3413, at the base of thesecond wire mesh structure 3405, acts to prevent the entirety of thedevice 3400 g from being passed through the pylorus. The combined wiremesh structures 3403, 3405 work together to occupy an increased volumein a patient's stomach and further delay the passage of food through thegastrointestinal tract. In an embodiment, the device 3400 g is coveredwith a protective covering such as a silicon or a PTFE sheath. In someembodiments, the first and second wire mesh structures 3403, 3405 aremade of hand braided Nitinol wires having a thickness in a range of 0.1mm to 1.0 mm and, more preferably, approximately 0.4 mm, and the sleeve3407 is made of machine braided Nitinol wires having a thickness in arange of 0.05 mm to 0.7 mm and, more preferably, approximately 0.127 mm.

In an embodiment, the device 3400 g has a total length of approximately100 to 850 mm. In an embodiment, the first wire mesh 3403 has a centraldiameter of approximately 90 mm. In an embodiment, the lengths of eachof the first wire mesh 3403 and the second wire mesh 3405 areapproximately 70 mm and a total length measured from the proximal end ofthe first wire mesh 3403, including the first anti-migration component3409, to the distal end of the second mesh 3405 is approximately 145 mm.In various embodiments, the diameter of an opening 3425 in the proximalend is approximately 5 mm to 25 mm and the diameter of an opening 3423in the distal end of the sleeve 3407 ranges from 5 mm to 35 mm. Also, inan embodiment, the width of the first anti-migration component 3409 atthe base of the first wire mesh structure 3403 is approximately 5 mm. Inan embodiment, the diameter of the sleeve 3407 is approximately 25 mm.Further, in an embodiment, an overall length of the sleeve isapproximately 505 mm, wherein the length from proximal point 3415 tomidpoint 3417 is approximately 137 mm, and the length from distal point3419 to distal end 3423 is approximately 57 mm.

FIG. 34I illustrates an intragastric device 3400 h having two wiremeshes coupled with an anti-migration feature, in accordance with anembodiment of the present specification. As shown, the device 3400 hcomprises a first wire mesh structure 3462 positioned on top of a secondwire mesh structure 3472 and an anti-migration collar 3473 coupled tothe distal end of the second wire mesh structure 3472. A firstanti-migration feature 3463 at the base of the first wire mesh structure3462 functions to couple the two wire mesh structures 3462, 3472together. The first anti-migration feature 3463 also helps to preventthe first wire mesh structure 3462 from being compressed by antralcontractions while the second wire mesh structure 3472 is beingcompressed by the antral contractions and keeps the device 3400 h out ofthe pylorus. The anti-migration collar 3473, at the base of the secondwire mesh structure 3472, acts to prevent the entirety of the device3400 g from being passed through the pylorus.

In various embodiments, the total length of device 3400 h ranges from 30mm to 300 mm. In an embodiment, the first wire mesh 3462 has a centraldiameter of approximately 90 mm, range 20 to 200. In an embodiment, thelengths of each of the first wire mesh 3462 and the second wire mesh3472 are in a range of 20 mm to 100 mm and, more preferably,approximately 70 mm, and a total length measured from the proximal endof the first wire mesh 3462, including the first anti-migration feature3463, to the distal end of the second mesh 3472 in a range of 30 mm to200 mm, and more preferably, approximately 145 mm. In an embodimentshown in FIG. 34J, the diameter of an opening 3465 in the proximal endis approximately 5 mm to 35 mm and the diameter of an opening 3475 inthe distal end ranges from 5 mm to 60 mm. Also, in an embodiment, thewidth of the first anti-migration component 3463 at the base of thefirst wire mesh structure 3462 is approximately 5 mm. In someembodiments, the length of the anti-migration collar 3473 ranges from 5mm to 100 mm. In embodiments, an inner diameter 3476 of anti-migrationcollar 3473 ranges from approximately 10 mm to 30 mm while an outerdiameter 3477 ranges from 25 mm to 77 mm.

In embodiments, (as explained with reference to FIGS. 3E and 3F), thewire mesh device 3400 h comprises a plurality of loops (FIGS. 34L and34M) formed in the wires of the first and second wire mesh structures3462, 3472 at their proximal and distal ends as well as the distal endof anti-migration collar 3473. In an embodiment, a thickness of the wireforming the loops, such as wire loop 3466, is approximately 0.4 mm and adiameter of a circular portion 3467 of wire loop 3466 is approximately 2mm. In an embodiment, the distal end of anti-migration collar 3473comprises 9 loops, such as the wire loop 3466 shown in FIGS. 34L and34M. In various embodiments, first anti-migration component 3463 isattached to the first and second wire mesh structure 3462, 3472 by meansof soft PTFE wires 3468 having a diameter of approximately 0.20 mm.Also, in embodiments, anti-migration collar 3473 is also attached to thewire mesh 3472 by means of soft PTFE wires 3438 having a diameter ofapproximately 0.20 mm.

FIG. 35 is an illustration of one single intragastric device 3530 beingpassed over a guidewire 3535 and attached to a previously deployedsingle intragastric device 3520 in a stomach 3512. A catheter 3521 isdepicted passing through the esophagus 3511 and into the stomach 3512.The catheter 3521 is deploying the second single intragastric device3530 and assisting in its attachment to the previously deployedintragastric device 3520. Operationally, the catheter 3521 will bepassed into an opening of the existing intragastric device 3520,preferably the opening used by the original catheter to deploy thedevice. The second device 3530 is then deployed with a portion of thesecond device, such as a neck, protrusion, or other member, fixedlyattached to the first device 3520, thereby anchoring the two devicestogether. In another embodiment, the two devices are pre-attachedoutside the body and are than deployed inside a human subject as asingle unit.

FIG. 36 is an illustration of a fully deployed combined intragastricdevice 3600 in a stomach 3612. The two single intragastric devices 3620,3630 are depicted attached one on top of the other, occupying a greaterstomach 3612 volume than one single intragastric device 3620.

FIGS. 37A and 37B are side and oblique perspective views, respectively,of another exemplary combined or dual-wire mesh intragastric device 3700in a post-deployment configuration, in accordance with an embodiment ofthe present specification. The pictured embodiment includes a first wiremesh structure 3701 flexibly connected, attached or coupled to a secondwire mesh structure 3702 to form a substantially dumbbell or barbellshaped intragastric device 3700. In a pre-deployment configuration,corresponding to a fully compressed or constrained state, the first wiremesh structure 3701 has a first volume and, in a post-deploymentconfiguration, corresponding to a fully expanded or relaxed state, thefirst wire mesh structure 3701 has a second volume. In variousembodiments, the first volume is less than the second volume. In apre-deployment configuration, corresponding to a fully compressed orconstrained state, the second wire mesh structure 3702 has a thirdvolume and, in a post-deployment configuration, corresponding to a fullyexpanded or relaxed state, the second wire mesh structure 3702 has afourth volume. In various embodiments, the third volume is less than thefourth volume.

In accordance with embodiments, the first wire mesh structure 3701 has afirst shape and size or dimension in a pre-deployment configuration anda second shape and size or dimension in a post-deployment configuration.In accordance with embodiments, the second wire mesh structure 3702 hasa third shape and size or dimension in a pre-deployment configurationand a fourth shape and size or dimension in a post-deploymentconfiguration. In some embodiments, the post-deployment shapes anddimensions are similar for the first and second wire mesh structures3701, 3702. In other embodiments, the post-deployment shapes anddimensions are dissimilar for the first and second wire mesh structures3701, 3702. In various embodiments, the post-deployment shapes aresubstantially spherical, oval, obloid, kidney bean, ovoid or invertedegg shapes.

In various embodiments of the present specification, the first wire meshstructure and/or the second wire mesh structure 3702 has a variablepost-deployment volume such that one or both can be expanded todifferent sizes. During deployment, variable levels of deployment sizeare used to check the position of the device and any deployment issues.For example, in some embodiments, the device is slowly deployed in stepsof deployment and is checked for appropriate deployment and positioningat the different steps. After full deployment, in some embodiments, thesize is fixed. In some embodiments, the two wire mesh structures areweaved separately or the wire mesh design in a single weave isdifferent, allowing for different stiffness, compression, and sizing ofthe two wire mesh structures.

In a preferred embodiment, the post-deployment shapes are substantiallyspherical or elliptical with similar dimensions.

In various embodiments, the present specification provides a wire meshdevice as a prosthetic that is sized small enough such that the devicemay be easily delivered via a catheter into a patient's body but is alsolarge enough such that it does not pass through the patient'santrum/pylorus and cause damage. In addition, the device is adequatelysized to be effective in sequestering food and delaying gastricemptying. For example, in various embodiments, a device having acombined post-deployment volume of less than 50 ml is not effective insequestering food and delaying gastric emptying and could be passedthrough the pylorus, while a device having a post-deployment volume ofgreater than 3,500 ml is too large and would adversely affect digestiveprocesses. Further, the wire mesh devices are not anchored orpermanently attached to any stomach structure, are free floating, andserve to position the optional sleeve in the patient's intestine,without a physician having to physically attach or anchor the sleeve tothe patient's GI tract. This allows both the mesh and sleeve structureto move relative to the GI tract wall. In various embodiments, thedevices are free to move about the stomach such that a patient's pylorusis blocked less than 100% of time and said blocking comprises less than100% of an opening defined by the pylorus. In various embodiments, thedevices block the pylorus over 50% of the time, more preferably over 90%of the time, and most preferably over 95% of the time.

In various embodiments, the wire mesh structures, both single and doublewire mesh configurations, of the intragastric devices of the presentspecification, provide several benefits over conventionalgastrointestinal space-occupying balloons. While traditional balloonscan be deformed by gastric pressure, the volume of the balloons issubstantially constant. High stomach wall pressure is reciprocated byfixed volume balloons and water filled balloons can create pressureulcers due to gravity and/or inertia. Air filled balloons can create agassy feeling in the patient. Since the volume of the wire mesh devicesof the present specification is variable, the wire mesh devices avoidthese problems. Additionally, over stretching trauma of the stomach wallcan occur with traditional balloons as food cannot enter the balloon.Food is intended to pass through the wire mesh devices of the presentspecification and therefore over stretching is not a concern. Theintragastric devices of the present specification also allow for delayedgastric emptying as food is retained in the wire mesh structure, abenefit that is not provided by traditional balloons. The constant lowoutward pressure of the wire mesh structures also induces satiety whilethe variable volume and shape provide natural comfort.

Table 1 lists ranges of post-deployment diameter, height, volume andpre-deployment compressed length of various intragastric double-meshdevices, in accordance with some embodiments of the presentspecification. In some embodiments, a double-mesh intragastric devicehas a post-deployment diameter, at its widest point, ranging from 20 to200 mm. More preferably, in some embodiments, a double-mesh intragastricdevice has a post-deployment diameter, at its widest point, ranging from50 to 150 mm, and, still more preferably, ranging from 80 to 100 mm. Inone embodiment, a double-mesh intragastric device has a post-deploymentdiameter of 90 mm. In some embodiments, a double-mesh intragastricdevice has a post-deployment height ranging from 45 to 400 mm. Morepreferably, in some embodiments, a double-mesh intragastric device has apost-deployment height ranging from 105 to 300 mm, and, still morepreferably, a post-deployment height of 145 mm. In some embodiments, afirst wire mesh structure has a first length equal to or less than 75cm, and more preferably, approximately 15 cm. In some embodiments, afirst wire mesh structure has a pre-deployment volume equal to or lessthan 5 ml, and more preferably, equal to or less than 110 ml and apost-deployment volume equal to or greater than 5 ml, and morepreferably, equal to or greater than 125 ml. In some embodiments, asecond wire mesh structure has a second length equal to or less than 70cm. In some embodiments, a second wire mesh structure has apre-deployment volume equal to or less than 5 ml, and more preferably,equal to or less than 100 ml and a post-deployment volume equal to orgreater than 5 ml, and more preferably, equal to or greater than 110 ml.In some embodiments, the first wire mesh structure has a post deploymentvolume greater than 5 ml and less than 5000 ml. In some embodiments, thesecond wire mesh structure has a post deployment volume greater than 20ml and less than 4000 ml. In some embodiments, a double-meshintragastric device has a post-deployment volume (both meshes together)ranging from 8 to 8381 ml. More preferably, in some embodiments, adouble-mesh intragastric device has a post-deployment volume (bothmeshes together) ranging from 131 to 3536 ml, and, still morepreferably, ranging from 442 to 826 ml. In one embodiment, a double-meshintragastric device has a post-deployment volume (both meshes together)of 657 ml. In some embodiments, a double-mesh intragastric device has apre-deployment compressed length ranging from 63 to 629 mm.Pre-deployment compressed length refers to the total length of thedevice when compressed into a catheter for deployment into a subject'sbody. More preferably, in some embodiments, a double-mesh intragastricdevice has a pre-deployment compressed length ranging from 157 to 471mm, and, still more preferably, ranging from 236 to 290 mm. In oneembodiment, a double-mesh intragastric device has a pre-deploymentcompressed length of 269 mm.

TABLE 1 Diameter Height Volume (ml) Compressed (mm) (mm) two meshesLength (mm) 200 400 8381 629 150 300 3536 471 100 145 826 290 90 145 657269 80 145 442 236 50 105 131 157 20 45 8 63

Each of the first and second wire mesh structure 3701, 3702 has a top orupper half surface or hemisphere, a bottom or lower half surface orhemisphere and an interior volume defined by the respectivepost-deployment shapes and sizes or dimensions of the wire meshstructures 3701, 3702. The first wire mesh structure 3701 includes atleast one first opening (or first surface area of openings) 3705proximate the top or upper half surface or hemisphere and at least onesecond opening (or second surface area of openings) 3706 proximate thebottom or lower half surface or hemisphere such that food enters thestructure 3701 through the at least one first opening 3705, passesthrough the interior, and exits the structure 3701 through the at leastone second opening 3706. The second wire mesh structure 3702 includes atleast one third opening (or third surface area of openings) 3707proximate the top or upper hemisphere and at least one fourth opening(or fourth surface area of openings) 3708 proximate the bottom or lowerhemisphere such that food enters the structure 3702 through the at leastone third opening 3707, passes through the interior, and exits thestructure 3702 through the at least one fourth opening 3708. In variousembodiments, the post-deployment shape of the first wire mesh structureincludes a first plurality of curved surfaces defined by an arc which isdetermined by a radius in a range of 0.2 cm to 20 cm and a central anglein a range of 5 to 175 degrees. In various embodiments, thepost-deployment shape of the second wire mesh structure includes asecond plurality of curved surfaces defined by an arc which isdetermined by a radius in a range of 0.1 cm to 15 cm and a central anglein a range of 1 to 179 degrees.

In accordance with some embodiments, the first and second wire meshstructures 3701, 3702 are porous structures. In other embodiments, thefirst and second wire mesh structures 3701, 3702 are substantiallycovered with a membrane to further impede the passage of food out of theintragastric device 3700. In various embodiments, the membrane covers10% to 99% of the device 3700 leaving only the at least one first,second, third and fourth openings 3705, 3706, 3707, 3708 uncovered. Thisdirects the food to enter the device 3700 through the at least one firstopening 3705 and leave the device 3700 through the at least one fourthopening 3708.

The first wire mesh structure 3701 includes a first plurality of freeends or nodes positioned at the at least one first opening 3705 and asecond plurality of free ends or nodes positioned at the at least onesecond opening 3706. The second wire mesh structure 3702 includes athird plurality of free ends or nodes positioned at the at least onethird opening 3707 and a fourth plurality of free ends or nodespositioned at the at least one fourth opening 3708. The pluralities ofnodes comprise bends or curves in the wires of the wire mesh structures3701, 3702 which are unsupported or not connected to other portions ofthe wire mesh. In other words, the pluralities of nodes are loops orbends comprising the free ends at each end of the wire mesh structures3701, 3702. In accordance with various embodiments, the first, second,third and fourth pluralities of nodes include hoops. In one embodiment,hoops are formed from twisting the free ends of the pluralities of nodesinto a hoop shape. In another embodiment, the hoops comprise separatewire hoops that are sutured to the free ends of the pluralities ofnodes.

In various embodiments, a connection is formed between a portion of aplurality of free ends of the first wire mesh structure defining saidsecond surface area of openings 3706 and a portion of a plurality offree ends of the second wire mesh structure defining said third surfacearea of openings 3707. In some embodiments, the connection comprises afirst flexible suture attached, at one end, to a first point on saidsecond surface area of openings 3706 and, at a second end, to a secondpoint on said third surface area of openings 3707. In variousembodiments, a length of the connection is in a range of 0 mm to 200 mmwherein a lower bound ranges from 0 mm to 2 mm and every incrementtherein. In some embodiments, the connection comprises a second flexiblesuture attached, at one end, to a third point on said second surfacearea of openings 3706 and, at a second end, to a fourth point on saidthird surface area of openings 3707 wherein said third point isdifferent from the first point and said fourth point is different fromthe second point. In various embodiments, a length of the connection,including the second flexible suture, is in a range of 0 mm to 300 mmwherein a lower bound ranges from 0 mm to 2 mm and every incrementtherein. In some embodiments, the connection comprises a third flexiblesuture attached, at one end, to a fifth point on said second surfacearea of openings 3706 and, at a second end, to a sixth point on saidthird surface area of openings 3707, wherein said fifth point isdifferent from the first point and the third point and wherein saidsixth point is different from the second point and the fourth point. Invarious embodiments, a length of the connection, including the thirdflexible suture, is in a range of 0 mm to 300 mm wherein a lower boundranges from 0 mm to 2 mm and every increment therein. In someembodiments, the connection comprises a fourth flexible suture attached,at one end, to a seventh point on said second surface area of openings3706 and, at a second end, to an eighth point on said third surface areaof openings 3707, wherein said seventh point is different from said thefirst point, the third point, and the fifth point and wherein saideighth point is different from the second point, the fourth point, andthe sixth point. In various embodiments, a length of the connection,including the second flexible suture, is in a range of 0 mm to 300 mmwherein a lower bound ranges from 0 mm to 2 mm and every incrementtherein.

As shown in FIG. 37C, in accordance with an aspect of the presentspecification, a portion of the second pluralities of nodes 3701 n ofthe first wire mesh structure 3701 are flexibly connected, coupled orattached to a portion of the third pluralities of nodes 3702 n of thesecond wire mesh structure 3702 using a plurality of sufficiently loosesutures or suture knots 3710. Though sutures are depicted in FIG. 37C,in other embodiments, the flexible connection between the first wiremesh structure and the second wire mesh structure can comprise anyflexible member, such as a flexible metal wire or plastic component. Inthese other embodiments, a suture is not required. In some embodiments,the plurality of sutures 3710 includes at least two standalone flexibleconnection or suture points wherein at least two nodes of the secondpluralities of nodes 3701 n of the first wire mesh structure 3701 areflexibly coupled to at least two nodes of the third pluralities of nodes3702 n of the second wire mesh structure 3702. In a preferredembodiment, the plurality of sutures 3710 includes three or fourstandalone flexible connection or suture points. In various embodiments,a length of the connection between the openings on the lower surface ofthe first wire mesh structure and the openings on the upper surface ofthe second wire mesh structure is in a range of 0 mm-300 mm. In variousembodiments, the connection of the first wire mesh structure to thesecond wire mesh structure has a length such that the first wire meshstructure can be compressed up to a range of 1% to 99%, and morepreferably, 40% to 99%, and all increments therein, of its equatorialdiameter without leading to a compression of the second wire meshstructure. In various embodiments, the plurality of sutures 3710 aredistributed equidistantly along the peripheries of the second and thirdopenings 3706, 3707. FIG. 37E shows two connection or suture points 3711utilized to flexibly connect the first and second wire mesh structures3701, 3702. In an embodiment, the two connection or suture points 3711are separated from one another by 180 degrees.

In an alternate embodiment, the first and second wire mesh structures3701, 3702 are flexibly coupled by interweaving or meshing (instead ofusing a plurality of sutures or suture knots) a portion of the secondpluralities of nodes 3701 n of the first wire mesh structure 3701 to aportion of the third pluralities of nodes 3702 n of the second wire meshstructure 3702.

In an optional embodiment, as shown in FIG. 37D, a sleeve 3725, having aproximal end, a distal end, and a lumen, is coupled at its proximal endto the lower portion of the second wire mesh structure 3702. The sleeve3725 includes, at its proximal end, a first opening 3741 in fluidcommunication with the fourth opening or fourth surface area of openings(3708 of FIG. 37A) of the second wire mesh structure 3702 and a secondopening 3742 at said distal end. In some embodiments, the sleeve 3725 iscoupled, via a plurality of sutures, to the fourth plurality of nodes3702 p of the second wire mesh structure 3702. The optionally coupledsleeve 3725, when deployed, extends from the patient's stomach into theduodenum where it empties, or, in other embodiments, through theduodenum and into the jejunum. In one embodiment, the sleeve 3725functions to transit sequestered food/chyme from the intragastric device3700 directly to the mid-duodenum or mid-jejunum.

Referring now to FIGS. 37A through 37C, it should be appreciated that,in various embodiments, the first and second wire mesh structures 3701,3702 are woven and constructed separately and flexibly attached orsutured, thereafter, either inside (as described earlier with referenceto FIGS. 35, 36) or outside a patient's body. It should also beappreciated that the coupling sutures can be cut for removal of the twostructures 3701, 3702 separately, from the patients' stomach.

In various embodiments, each of the connection or suture pointscomprises a figure eight knot, optionally, additionally secured withglue and a heat shrink tube. In one embodiment, each knot comprises 30lb. break-strength ultra-high-molecular-weight-polyethylene (UHMWPE)braided suture line to provide a reliable connection between the firstand second wire mesh structures 3701, 3702.

In accordance with various aspects of the present specification, theflexible connection or attachment of the first and second wire meshstructures 3701, 3702, using the plurality of sutures 3710, and theresultant intragastric device 3700 provides various benefits andfunctionalities (discussed below).

The flexible connection or attachment enables a fluid communicationbetween the first and second wire mesh structures 3701, 3702. That is,food first passes through the at least one first opening 3705 in the topof the combined intragastric device 3700 and is sequestered in the firstwire mesh structure 3701. The food then slowly passes into, and issequestered in, the second wire mesh structure 3702. Finally, the foodslowly releases through the at least one fourth opening 3708 in thebottom of the combined intragastric device 3700 and back into thestomach. The connected wire mesh structures 3701, 3702 work together tooccupy an increased volume in a patient's stomach and further delay thepassage of food through the gastrointestinal tract. The connected twowire mesh structures 3701, 3702 also act to induce satiety even morequickly and induce a longer lasting satiety than a single mesh structuredevice.

The flexible connection or attachment enables the first and second wiremesh structures 3701, 3702 to pivot, bend or move in substantially alldirections relative to each other. Referring to FIG. 37F, the first wiremesh structure 3701 has a first longitudinal axis 3715 passing through acenter of the first structure 3701, a center of a first surface area ofopenings 3721 at the proximal end of the first structure 3701, and acenter of a second surface area of openings 3722 at the distal end ofthe first structure while the second wire mesh structure 3702 has asecond longitudinal axis 3716 passing through a center of the secondstructure 3702, a center of a third surface area of openings 3731 at aproximal end of the second structure 3702, and a center of a fourthsurface area of openings 3732 at a distal end of the second structure. Adegree of movement of the two structures 3701, 3702, relative to eachother, is illustrated and defined by an angular displacement 3717between the first and second longitudinal axes 3715, 3716. In variousembodiments, the flexible connection points 3711 enable the first andsecond wire mesh structures 3701, 3702 to have a degree of movement (orangular displacement 3717 between the first and second longitudinal axes3715, 3716) of up to 90 degrees relative to each other in alldirections. In some embodiments, the connection of the first wire meshstructure to the second wire mesh structure has a length such that, uponmore than 90% compression of the first wire mesh structure, the secondwire mesh structure has an angular displacement relative to the firstwire mesh structure of 10% or less.

During a process of deployment, the flexible connection or attachmentenables one wire mesh structure, for example the first wire meshstructure 3701, to open almost completely without the need to deploy theother wire mesh structure, for example the second wire mesh structure3702. FIG. 38A illustrates a process of deployment of a combinedintragastric device 3800. As shown, the device 3800 further includes acatheter or over-tube 3820 wherein a first wire mesh structure 3801 isnearly or almost completely deployed while a second wire mesh structure3802, connected or attached to the first wire mesh structure 3801 via aplurality of sutures 3810, is still constrained serially within thecatheter or over-tube 3820. In some embodiments, the catheter 3820comprises a housing and a lumen extending through the housing. In someembodiments, the lumen has a diameter equal to or less than 2 cm, andmore preferably, approximately 0.9 cm. On compression of one wire meshstructure, for example the second wire mesh structure 3702, into atubular structure (such as an over-tube or catheter) during a process ofwithdrawal or removal, the flexible connection or attachment enablesalignment of the other wire mesh structure, for example the first wiremesh structure 3701, to be compressed into the tubular structure. FIGS.38B through 38D illustrate a process of withdrawal or removal of thecombined intragastric device 3800. As shown in FIG. 38B, the second wiremesh structure 3802 is partially compressed as it is being withdrawninto the catheter 3820 using a grasper 3822 through an endoscope 3825(for example), while the first wire mesh structure 3801 remainsunconstrained or in a deployed configuration. As the second wire meshstructure 3802 is fully compressed due to its full withdrawal into thecatheter 3820, as shown in FIG. 38C, the plurality of sutures 3810enable alignment or orientation of the first wire mesh structure 3801for compression into the catheter 3820 for removal. Finally, as shown inFIG. 38D, the aligned or oriented first wire mesh structure 3801 beginsgetting constrained or compressed into the catheter 3820 for removal, asthe fully compressed second wire mesh structure 3802 is furtherwithdrawn into the catheter 3820 using the endoscope 3825.

Thus, the flexible connection or attachment enables one wire meshstructure to be compressed or withdrawn and released or deployedindependent of the other wire mesh structure.

Referring now to FIGS. 37A through 37F, it should be noted that theplurality of sutures 3710 need to be long enough to enable the pivoting,bending or relative degree of movement of the two wire mesh structures3701, 3702 but short enough to communicate compression forces from onewire mesh structure (as it is being withdrawn or deployed) to the otherwire mesh structure. In some embodiments, one wire mesh structure can becompressed up to 99% of its equatorial diameter (in embodiments wherethe first and second wire mesh structures 3701, 3702 are substantiallyspherical) without radially compressing the other wire meshstructure—but beyond that, the compression is communicated. This has ananti-migration advantage in that the intragastric device 3700 isunlikely to pass through a fully relaxed pylorus even if one of the twowire mesh structures is substantially compressed while in apost-deployment configuration. In various embodiments, a length of aconnection or suture point, from a node of the second pluralities ofnodes to a node of the third pluralities of nodes, is in a range of 1 mmand twice the diameter of the third opening 3707 of the second wire mesh3702 (FIGS. 37A, 37B).

The combined or dual-wire mesh intragastric device 3700 of the presentspecification provides various benefits or advantages compared todeploying a single large device. Firstly, the combined intragastricdevice 3700 offers better protection against migration of the device3700 through a relaxed pylorus of a patient. If a single large devicegets compressed it can migrate relatively easily through the relaxedpylorus. However, it is unlikely for both the wire mesh structures 3701,3702 of the intragastric device 3700 to be compressed accidentallythereby offering mitigation against migration risk.

Secondly, a single large device will be relatively inflexible, thereby,putting excessive pressure against the patient's stomach lining, atleast for some of the time. In contrast, the intragastric device 3700has a sufficiently large post-deployment structure or occupied volumewhile still minimizing excessive pressure against the stomach wall (andprevent abrasions on the stomach wall or lining) because theintragastric device 3700 will bend and move (owing to the flexibleconnection or attachment of the two connected wire mesh structures 3701,3702), thereby better suiting the stomach contours. Thus, theintragastric device 3700 of the present specification, when deployed,offers improved balance or optimization between a need to occupy a largestomach volume and a need to minimize pressure on the stomach. Invarious embodiments, the intragastric device 3700, when deployed,occupies 25% to 95% of the gastric volume or the patient's stomachvolume.

It should be appreciated that the present disclosure is intended toprovide a teaching of several exemplary embodiments of the presentinvention and is should not be limited to the specific structuresdisclosed herein. Other variations of the disclosed embodiments, whichwould be understood by those of ordinary skill, are covered by thepresent application and are within the scope of the invention, asfurther defined by the claims.

We claim:
 1. An intragastric device configured for deployment in astomach of a person, the device comprising: a first structure that iscompressible to a pre-deployment shape having a first volume andexpandable to a post-deployment shape having a second volume that isporous, enclosed, and defined by a first plurality of curved surfacesand that is greater than the first volume, the first structure having anupper portion and a lower portion, the upper portion having a firstsurface area of openings configured to permit material to enter fromoutside the second volume to inside the second volume and the lowerportion having a second surface area of openings; a second structurehaving a pre-deployment shape that is compressible to a pre-deploymentshape having a third volume and expandable to a post-deployment shapehaving a fourth volume that is a porous, enclosed and defined by asecond plurality of curved surfaces and that is greater than the thirdvolume, the second structure further comprising an upper portion and alower portion wherein the upper portion of the second structure has athird surface area of openings configured to permit material to enterfrom outside the fourth volume to inside the fourth volume and the lowerportion of the second structure has a fourth surface area of openings; aplurality of flexible members extending between and coupling the firstand second structures, the plurality of flexible members beingsufficiently loose between the first and second structures to permitcompression of the first wire mesh structure to at least 40% of itsdiameter without leading to a compression of the second wire meshstructure.
 2. The intragastric device of claim 1 wherein each flexiblemember comprises a flexible metal wire.
 3. The intragastric device ofclaim 1, wherein each flexible member comprises a plastic component. 4.The intragastric device of claim 1, wherein each flexible membercomprises a suture.
 5. The intragastric device of claim 1 wherein theflexible members permit compression of the first wire mesh structure toat least 70% of its diameter without leading to the compression of thesecond wire mesh structure.
 6. The intragastric device of claim 1wherein the flexible members permit compression of the first wire meshstructure to at least 90% of its diameter without leading to thecompression of the second wire mesh structure.
 7. The intragastricdevice of claim 1 wherein the flexible members permit compression of thefirst wire mesh structure to at least 95% of its diameter withoutleading to the compression of the second wire mesh structure.
 8. Theintragastric device of claim 1 wherein the flexible members permitcompression of the first wire mesh structure to 99% of its diameterwithout leading to the compression of the second wire mesh structure. 9.The intragastric device of claim 1, wherein at least one of the firstplurality of curved surfaces is defined by an arc and wherein the arc isdetermined by a radius in a range of 0.2 cm to 20 cm and a central anglein a range of 5 to 175 degrees.
 10. The intragastric device of claim 10,wherein at least one of the second plurality of curved surfaces isdefined by an arc and wherein the arc is determined by a radius in arange of 0.1 cm to 15 cm and a central angle in a range of 1 to 179degrees.
 11. The intragastric device of claim 1, wherein the pluralityof flexible members are formed by interweaving or meshing a firstplurality of nodes of the first wire mesh structure to a secondplurality of nodes of the second wire mesh structure.
 12. Theintragastric device of claim 1, wherein the first wire mesh structurehas at least one of a spherical and elliptical shape.
 13. Theintragastric device of claim 12, wherein the second wire mesh structurehas at least one of a spherical and elliptical shape.
 14. Theintragastric device of claim 1, wherein each flexible member comprises afigure eight knot.
 15. The intragastric device of claim 14, wherein eachfigure eight knot is secured with an adhesive and a heat shrink tube.16. The intragastric device of claim 14, wherein each figure eight knoteach knot comprises a ultra-high-molecular-weight-polyethylene braidedsuture line.
 17. An implantable device comprising: a first structurethat is expandable from a pre-deployment shape having a first volume toa post-deployment shape having a second volume that is porous, enclosed,and defined by a first plurality of curved surfaces and that is greaterthan the first volume, the first structure having an upper portion and alower portion, the upper portion having a first surface area of openingsconfigured to permit material to enter from outside the second volume toinside the second volume; a second structure having a pre-deploymentshape that is compressible to a pre-deployment shape having a thirdvolume and expandable to a post-deployment shape having a fourth volumethat is a porous, enclosed and defined by a second plurality of curvedsurfaces and that is greater than the third volume, the second structurefurther comprising an upper portion and a lower portion wherein theupper portion of the second structure has a third surface area ofopenings configured to permit material to enter from outside the fourthvolume to inside the fourth volume; a flexible coupling between thefirst and second structures that is sufficiently to permit compressionof the first wire mesh structure to at least 40% of its diameter withoutleading to a compression of the second wire mesh structure.
 18. Thedevice of claim 1 wherein the flexible members permit compression of thefirst wire mesh structure to at least 70% of its diameter withoutleading to the compression of the second wire mesh structure.
 19. Thedevice of claim 1 wherein the flexible members permit compression of thefirst wire mesh structure to at least 90% of its diameter withoutleading to the compression of the second wire mesh structure.
 20. Thedevice of claim 1 wherein the flexible members permit compression of thefirst wire mesh structure to at least 95% of its diameter withoutleading to the compression of the second wire mesh structure.
 21. Thedevice of claim 1 wherein the flexible members permit compression of thefirst wire mesh structure to 99% of its diameter without leading to thecompression of the second wire mesh structure.